Ambulatory medicament pump with safe access control

ABSTRACT

Systems and methods are disclosed herein for managing access to therapy controls of an ambulatory medicament pump that provides therapy to a subject using safe access levels associated with the therapy controls. The therapy change controls may enable modification of the corresponding therapy control parameters. The disclosed systems and methods can determine the eligibility of a subject receiving therapy from the ambulatory medicament pump or a user of the ambulatory medicament pump, for a safe access level and provide access to the corresponding therapy change controls. The ambulatory medicament pump may provide access to the therapy change controls upon receiving an access signal. In some cases, the ambulatory medicament pump may receive a time-based passcode and provide access to the therapy change controls upon receiving a matching passcode from the user.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of PCT Application No.PCT/US2021/072742, filed Dec. 3, 2021, which claims priority to U.S.Provisional Patent Application Nos. 63/122,427, filed Dec. 7, 2020;63/169,112, filed Mar. 31, 2021; 63/151,565, filed Feb. 19, 2021;63/261,290, filed Sep. 16, 2021; 63/128,428, filed Dec. 21, 2020;63/152,744, filed Feb. 23, 2021; 63/157,541, filed Mar. 5, 2021;63/152,716, filed Feb. 23, 2021; 63/168,203, filed Mar. 30, 2021;63/212,521, filed Jun. 18, 2021; 63/139,210, filed Jan. 19, 2021;63/276,481, filed Nov. 5, 2021; 63/215,857, filed Jun. 28, 2021;63/183,900, filed May 4, 2021; 63/167,563, filed Mar. 29, 2021;63/216,177, filed Jun. 29, 2021; 63/249,975, filed Sep. 29, 2021;63/194,126, filed May 27, 2021; 63/239,365, filed Aug. 31, 2021;63/263,602, filed Nov. 5, 2021; 63/264,645, filed Nov. 29, 2021, and63/238,670, filed Aug. 30, 2021. The entire contents of each applicationreferenced in this paragraph are hereby incorporated by reference hereinfor all purposes and made part of this specification. Any and allapplications for which a foreign or domestic priority claim isidentified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND Technical Field

This disclosure relates to glucose control systems, including medicaldevices that provide glucose control therapy to a subject, glucose levelcontrol systems, and ambulatory medicament pumps that deliver medicamentto the subject to control blood glucose level in the subject.

Description of Related Art

Sustained delivery, pump driven medicament injection devices generallyinclude a delivery cannula mounted in a subcutaneous manner through theskin of the subject at an infusion site. The pump draws medicine from areservoir and delivers it to the subject via the cannula. The injectiondevice typically includes a channel that transmits a medicament from aninlet port to the delivery cannula which results in delivery to thesubcutaneous tissue layer where the delivery cannula terminates. Thedelivery of medicament by the pump is controlled by a controller basedon values of one or more control parameters and/or a measured glucoselevel in the subject. Some infusion devices are configured to deliverone medicament to a subject while others are configured to delivermultiple medicaments to a subject.

SUMMARY

Glucose control systems, such as blood glucose control systems, andambulatory medical devices that provide therapy to a subject, such asblood glucose control, are disclosed. Disclosed systems and devices canimplement one or more features that improve the user experience, such assoftware update techniques that avoid interrupting delivery of therapy,gesture-based control of therapy delivery, automatic resumption oftherapy after a user-initiated pause, improved alarm management, displayof autonomously calculated dosing recommendations, wide area networkconnectivity, and security features.

BRIEF DESCRIPTION OF THE DRAWINGS

The systems, methods, and devices of this disclosure each have severalinnovative aspects, no single one of which is solely responsible for allof the desirable attributes disclosed herein. Details of one or moreimplementations of the subject matter described in this specificationare set forth in the accompanying drawings and the description below.The drawings are provided to illustrate certain aspects of the subjectmatter described herein and not to limit the scope thereof.

FIG. 1A illustrates an example blood glucose control system thatprovides blood glucose control via an ambulatory medicament pump.

FIG. 1B illustrates another example blood glucose control system thatprovides blood glucose control via an ambulatory medicament pump.

FIG. 1C illustrates a further example blood glucose control system thatprovides blood glucose control via an ambulatory medicament pump.

FIG. 2A shows a block diagram of an example blood glucose controlsystem.

FIG. 2B shows a block diagram of another example blood glucose controlsystem.

FIG. 2C shows a block diagram of another example blood glucose controlsystem.

FIG. 2D shows a block diagram of another example blood glucose controlsystem.

FIG. 3 is a schematic of an example glucose control system that includesan electronic communications interface.

FIG. 4A shows a block diagram of an example blood glucose control systemin online operation mode.

FIG. 4B shows a block diagram of an example blood glucose control systemin offline operation mode.

FIG. 5A illustrates a perspective view of an example ambulatory medicaldevice.

FIG. 5B illustrates a cross sectional view of the ambulatory medicaldevice shown in FIG. 5A.

FIG. 6 illustrates different systems that may be included in an exampleambulatory medical pump (AMP).

FIG. 7 illustrates various communication links that the AMP may use toestablish a communication connection with an electronic device.

FIG. 8A shows a block diagram of an example system for managing accessto therapy settings of an AMP.

FIG. 8B shows a block diagram of another example system for managingaccess to therapy settings of an AMP.

FIG. 8C shows a block diagram of another example system for managingaccess to therapy settings of an AMP.

FIG. 9 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMP to provide access to the therapychange controls associated with a safe access level using a passcode.

FIG. 10 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMP to provide access to the therapychange controls associated with a safe access level using an accesssignal.

FIG. 11 is a flow diagram showing an example of a computer-implementedmethod that may be used by an electronic evaluation device to determinea safe access level for a user or a subject and provide access totherapy change controls associated with the determined or selected safeaccess level.

FIG. 12 is a flow diagram showing an example of a computer-implementedmethod that may be used by an electronic evaluation device to determinethe eligibility of the user or the subject for a selected safe accesslevel, and provide access to therapy change controls associated with theselected safe access level.

FIG. 13A shows a block diagram of an example system and method formanaging to the therapy change controls of an AMP associated with a safeaccess level using a passcode generated by an electronic passcodedevice.

FIG. 13B shows a block diagram of an example system and method formanaging access to therapy change controls of an AMP using an accesscode generated by an electronic configuration device.

FIG. 14 shows a flow diagram showing an example of acomputer-implemented method that may be used by an electronicconfiguration device to generate an access code usable by a glucosecontrol system to modify or change a glucose level therapy controlconfiguration of the glucose level control system in accordance withcertain embodiments.

FIG. 15 shows a flow diagram showing an example of acomputer-implemented method that may be used by the glucose controlsystem of an ambulatory medicament device to enable or activate arequested glucose level therapy control configuration of the glucosecontrol system.

FIG. 16 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMD in order to detect and download anapplication update.

FIG. 17 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMD to install a down-loaded applicationupdate without interrupting the therapy provided to a subject.

FIG. 18 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMD to install a second update downloadedfrom a host computing system and switch control of the AMD from a firstapplication to the second application without interrupting the therapyprovided to a subject.

FIG. 19 is a flow diagram showing an example of a computer-implementedmethod that may be used by an AMD to install a second applicationdownloaded from a host computing system, verify and switch control ofthe AMD from a first application to the second application withoutinterrupting the therapy provided to a subject, only if the secondapplication satisfies a minimum set of operation conditions.

FIG. 20 is a flow diagram showing an example of a computer-implementedmethod that may be used to respond to detection of an application faultduring the execution of a first version of an application and switchingcontrol of the AMD to a second version an application installed on theAMD.

FIG. 21 is a flow diagram showing an example of a computer-implementedmethod that may be used to respond to detection of an application faultduring the execution of a first version of an application and switchingcontrol of the AMD to a second version an application installed on theAMD and/or downloading a third version of the application.

FIG. 22. is a block diagram, illustrating an example networkconfiguration wherein the AMD is directly connected to a computingsystem and the computing system shares the therapy reports with one ormore display systems and the AMD.

FIG. 23 is a flow diagram illustrating an example method that may beused by a computing system, to generate and share a therapy report basedon encrypted therapy data received from an AMD.

FIG. 24. is a block diagram, illustrating an example network and dataflow configuration wherein the AMD is directly connected to a computingsystem and the computing system generates and sends alerts to one ormore display systems and the AMD.

FIG. 25 is a flow diagram illustrating an example method that may beused by a computing system, to generate and send an alert to one or moreauthorized devices.

FIG. 26 illustrates the interconnection among modules and procedures inAMD involved in receiving, accepting and/or canceling therapy changerequest.

FIG. 27 is a flow diagram illustrating an example method that may beused by an AMD to allow a user to change the configuration of theambulatory medicament device using a touch screen user interface.

FIG. 28A is an illustration of the touchscreen display of an example AMDafter the touch screen is waked/unlocked by a wake action of a user andbefore the first user gesture is received.

FIG. 28B is an illustration of an example touchscreen display that mayprompt the user to enter a predetermined series of inputs for the firstgesture or second gesture.

FIG. 28C is an illustration of an example therapy change user interface.

FIG. 28D is an illustration of another therapy change user interface ona touchscreen display.

FIG. 29 is a flow diagram illustrating an example method that may beused by an AMD to generate an alarm status indicator.

FIG. 30 is a flow diagram illustrating an example method that may beused to cancel a therapy change using a touchscreen interface.

FIG. 31A is an illustration of a touchscreen display alerting the userthat the delivery of one or more medicaments will occur.

FIG. 31B is an illustration of a touchscreen display showing that amedicament is being delivered to the user.

FIG. 32 is a block diagram illustrating the interconnection amongmodules and procedures in AMD involved in receiving, accepting and/orcanceling a therapy suspension request.

FIG. 33 is a flow diagram illustrating an example method for receivingand implementing a suspension request, which may be implemented by anAMD

FIG. 34 illustrates a plurality of user interface screens that theambulatory medical device may display when a user pauses therapy.

FIG. 35 is a flow diagram illustrating an example method of resuming asuspended therapy that may be implemented by an AMD.

FIG. 36 illustrates a plurality of user interface screens that theambulatory medical device may display when a user resumes therapy.

FIG. 37 is a block diagram illustrating the interconnection amongmodules and procedures in AMD involved in changing the settings of theAMD.

FIG. 38 is a flow diagram illustrating an example method that may beused by an AMD to allow a user to change a setting of the AMD using auser generated passcode or an override passcode.

FIG. 39 is a flow diagram illustrating an example method that may beused by an AMD to allow a user to change a setting of the AMD using auser generated passcode or an override passcode.

FIG. 40 is a schematic diagram illustrating the interconnection amongmodules and procedures in AMD involved in monitoring the status of theAMD and/or the subject and generate alarms when an alarm condition ismet.

FIG. 41 is a flow diagram illustrating an example procedure that may beused by the alarm system of an AMD to annunciate an alarm condition uponreceiving a status information that satisfies an alarm condition.

FIG. 42 is a block diagram illustrating the interconnection amongmodules and procedures in AMD involved in monitoring the condition ofthe AMD and generating alerts when a device malfunction is detected.

FIG. 43 is a flow diagram illustrating an example procedure that may beused by the alert system of an AMD to monitor the operation of an AMDand generate alerts when a device malfunction is detected.

FIG. 44 is a schematic diagram illustrating an ambulatory medical devicethat provides the user with various options for providing medicament.

FIG. 45 is a flow diagram of a process for providing options for mealdosage selection on an ambulatory device.

FIG. 46 is another flow diagram of a process for providing options formeal dosage selection on an ambulatory device.

FIG. 47 is a series of user interface screen displays showing a userinitiating the activation of meal dosage on an ambulatory device.

FIG. 48 is a series of user interface screen displays showing a useractivating meal dosage on an ambulatory device.

FIG. 49 is a series of user interface screen displays showing a useractivating meal announcement on an ambulatory device.

FIG. 50 is a series of user interface screen displays showing a userinputting the total number of units on an ambulatory device.

FIG. 51 is a series of user interface screen displays showing anambulatory medical device delivering the units and cancelling thedelivery of the units.

FIG. 52 is a schematic illustrating a computer system that can beimplemented in various embodiments of the described subject matter.

FIG. 53 shows an example control system configured to transferhistorical pump data from a first ambulatory medicament pump to a secondambulatory medicament pump.

FIG. 54 shows a flow diagram illustrating an example method that may beused by a control system to transfer historical pump data from a firstambulatory medicament pump to a second ambulatory medicament pump.

FIG. 55A shows an example medicament pump that is configured to storedata on a removable data module configured to be readable by a secondambulatory medicament pump.

FIG. 55B shows another example medicament pump that is configured towirelessly transmit state data to a second ambulatory medicament pump.

FIG. 56 shows a flow diagram illustrating an example method that may beused by a medicament pump to store data on a removable data module of afirst ambulatory medicament pump configured to be readable by a secondambulatory medicament pump.

FIG. 57 shows a flow diagram illustrating an example method that may beused by a medicament pump to wirelessly transmit from the medicamentpump one or more of a plurality of glucose control parameters andglucose control therapy data to a second ambulatory medicament pump.

FIG. 58 illustrates a block diagram of a glucose level control system inaccordance with certain embodiments.

FIG. 59 illustrates a block diagram of a controller system in accordancewith certain embodiments.

FIG. 60 presents a flowchart of an example carbohydrate therapyequivalence tracking process in accordance with certain embodiments.

FIG. 61 presents a flowchart of an example backup therapy protocolgeneration process in accordance with certain embodiments.

FIG. 62 presents a flowchart of an example control parametermodification tracking process in accordance with certain embodiments.

FIG. 63 illustrates an example backup therapy protocol in accordancewith certain embodiments.

FIG. 64 illustrates an example control parameter modification report inaccordance with certain embodiments.

FIG. 65 illustrates an example meal selection report that may beincluded as part of some implementations of the control parametermodification report of FIG. 11 in accordance with certain embodiments.

FIG. 66 presents a flowchart of an example automated glucose controlrefinement process in accordance with certain embodiments.

FIG. 67A illustrates a simulation of glucose control of a subject withTmax set to 65 minutes.

FIG. 67B illustrates a simulation of glucose control of a subject withTmax set to 15 minutes.

FIG. 67C illustrates a simulation of glucose control of a subject withTmax set to 130 minutes.

FIG. 68 illustrates an example of blood glucose level signal (CGM trace)and some of the parameters associated with glycemic control using aglucose level control system.

FIG. 69 presents a flowchart of an example automated glucose controlrefinement process based on an adjustment function in accordance withcertain embodiments.

FIG. 70 illustrates some examples of statistical quantities that may begenerated and utilized by the glucose level control system as part ofstatistical analysis.

FIG. 71 presents a flowchart of an example automated glucose controlrefinement process in accordance with certain embodiments.

FIG. 72 presents a flowchart of an example configuration code generationprocess for customizing a glucose level control system.

FIG. 73 presents a flowchart of an example configuration process forcustomizing a glucose level control system based on a receivedconfiguration code.

FIG. 74 presents a flowchart of an example configuration process forcustomizing a glucose level control system based on a receivedconfiguration code that includes a reference or link to downloadableconfiguration data.

FIG. 75 shows a blood glucose control system disposed within amedicament pump operatively coupled to the subject.

FIG. 76 shows a blood glucose control system that is disposed within aglucose sensor system.

FIG. 77 shows a flow diagram illustrating an example method that may beused by a blood glucose control system to calculate a dose controlsignal for commanding administration of glucose control therapy to asubject.

FIG. 78 shows a flow diagram illustrating an example method that may beused by a blood glucose control system to transmit blood glucose controlparameters to a remote electronic device in response to anidentification of a triggering condition.

FIG. 79 shows a flow diagram illustrating an example method that may beused by a blood glucose control system receive an encoded pump statussignal and an encoded medicament delivery signal from a pump controller.

FIG. 80 shows a flow diagram illustrating an example method that may beused by a blood glucose control system to route pass-through dataunrelated to a glucose level signal to a target electronic device

DETAILED DESCRIPTION

Some embodiments described herein pertain to medicament infusion systemsfor one or more medicaments and the components of such systems (e.g.,infusion pumps, medicament cartridges, cartridge connectors, lumenassemblies, infusion connectors, infusion sets, etc.). Some embodimentspertain to methods of manufacturing infusion systems and componentsthereof. Some embodiments pertain to methods of using any of theforegoing systems or components for infusing one or more medicaments(e.g., pharmaceutical, hormone, etc.) to a subject. As an exemplaryillustration, an infusion system may include an infusion pump, which caninclude one or more medicament cartridges or can have an integratedreservoir of medicament. An infusion system may include medicamentcartridges and cartridge connectors, but not a pump. An infusion systemmay include cartridge connectors and an infusion pump, but notmedicament cartridges. An infusion system may include infusionconnectors, a lumen assembly, cartridge connectors, an infusion pump,but not medicament cartridges or an infusion set. A blood glucosecontrol system can operate in conjunction with an infusion system toinfuse one or more medicaments, including at least one blood glucosecontrol agent, into a subject. Any feature, structure, component,material, step, or method that is described and/or illustrated in anyembodiment in this specification can be used with or instead of anyfeature, structure, component, material, step, or method that isdescribed and/or illustrated in any other embodiment in thisspecification. Additionally, any feature, structure, component,material, step, or method that is described and/or illustrated in oneembodiment may be absent from another embodiment.

Some embodiments described herein pertain to medicament infusion systemsfor one or more medicaments and the components of such systems (e.g.,infusion pumps, medicament cartridges, cartridge connectors, lumenassemblies, infusion connectors, infusion sets, etc.). Some embodimentspertain to methods of manufacturing infusion systems and componentsthereof. Some embodiments pertain to methods of using any of theforegoing systems or components for infusing one or more medicaments(e.g., pharmaceutical, hormone, etc.) to a patient. As an exemplaryillustration, an infusion system may include an infusion pump, which caninclude one or more medicament cartridges or can have an integratedreservoir of medicament. An infusion system may include medicamentcartridges and cartridge connectors, but not a pump. An infusion systemmay include cartridge connectors and an infusion pump, but notmedicament cartridges. An infusion system may include infusionconnectors, a lumen assembly, cartridge connectors, an infusion pump,but not medicament cartridges or an infusion set. A glucose levelcontrol system can operate in conjunction with an infusion system toinfuse one or more medicaments, including at least one glucose controlagent, into a subject. Any feature, structure, component, material,step, or method that is described and/or illustrated in any embodimentin this specification can be used with or instead of any feature,structure, component, material, step, or method that is described and/orillustrated in any other embodiment in this specification. Additionally,any feature, structure, component, material, step, or method that isdescribed and/or illustrated in one embodiment may be absent fromanother embodiment.

Further, certain embodiments disclosed herein relate to a glucose levelcontrol system that is capable of supporting different operating modesassociated with different adaptation ranges used to generate dosecontrol signals for delivering medicament to a subject. The differentadaptation ranges may be associated with a value or a change in value ofone or more control parameters used by a control algorithm that controlsthe administering of medicament to a subject. In some non-limitingexamples, the control parameter may be associated with the quantity ofmedicament, a delivery rate of medicament, a step-size or graduationused to modify the quantity of medicament between administrations of themedicament, a timing of supplying medicament to the subject, a glucoseabsorption rate, a time until the concentration of insulin in bloodplasma for a subject reaches half of the maximum concentration, a timeuntil the concentration of insulin in blood plasma for a subject reachesa maximum concentration, or any other control parameter that can impacta timing or quantity of medicament (e.g., insulin or counter-regulatoryagent) supplied or administered to a subject.

Advantageously, in certain embodiments, supporting different operatingmodes enables a user (e.g., a healthcare provider, parent, guardian, thesubject receiving treatment, etc.) to modify the operating mode of anambulatory medicament device. In some cases, the operating mode may bemodified automatically. Moreover, modifying the operating mode enablesdifferent dosing modes to be supported. Advantageously, supportingdifferent dosing modes enables an ambulatory medicament device to beused by different types of subjects, and/or a subject under differentconditions (e.g., when exercising, before, during, or after puberty,under different health conditions, etc.).

Some embodiments described herein pertain to medicament infusion systemsfor one or more medicaments and the components of such systems (e.g.,infusion pumps, medicament cartridges, cartridge connectors, lumenassemblies, infusion connectors, infusion sets, etc.). Some embodimentspertain to methods of manufacturing infusion systems and componentsthereof. Some embodiments pertain to methods of using any of theforegoing systems or components for infusing one or more medicaments(e.g., pharmaceutical, hormone, etc.) to a subject. As an exemplaryillustration, an infusion system may include an infusion pump, which caninclude one or more medicament cartridges or can have an integratedreservoir of medicament. An infusion system may include medicamentcartridges and cartridge connectors, but not a pump. An infusion systemmay include cartridge connectors and an infusion pump, but notmedicament cartridges. An infusion system may include infusionconnectors, a lumen assembly, cartridge connectors, an infusion pump,but not medicament cartridges or an infusion set. A blood glucosecontrol system can operate in conjunction with an infusion system toinfuse one or more medicaments, including at least one blood glucosecontrol agent, into a subject. Any feature, structure, component,material, step, or method that is described and/or illustrated in anyembodiment in this specification can be used with or instead of anyfeature, structure, component, material, step, or method that isdescribed and/or illustrated in any other embodiment in thisspecification. Additionally, any feature, structure, component,material, step, or method that is described and/or illustrated in oneembodiment may be absent from another embodiment.

Some embodiments described herein pertain to medicament infusion systemsfor one or more medicaments. Some embodiments pertain to methods ofusing infusion systems for infusing one or more medicaments (e.g.,pharmaceutical, hormone, etc.) to a subject. Some embodiments pertain tomethods of managing access to one or more therapy settings of amedicament infusion system. As an exemplary illustration, an infusionsystem may include an infusion pump, which can include one or moremedicament cartridges or can have an integrated reservoir of medicament.An infusion system may include medicament cartridges and cartridgeconnectors, but not a pump. An infusion system may include cartridgeconnectors and an infusion pump, but not medicament cartridges. Aninfusion system may include infusion connectors, a lumen assembly,cartridge connectors, an infusion pump, but not medicament cartridges oran infusion set. A blood glucose control system can operate inconjunction with an infusion system to infuse one or more medicaments,including at least one blood glucose control agent, into a subject. Aninfusion system may include a user interface that allow modifying one ormore control parameters that control medicament delivery to a subject.An infusion system may include a wireless transceiver that allows datacommunication between the infusion system and one or more electronicdevices.

Any feature, structure, component, material, step, or method that isdescribed and/or illustrated in any embodiment in this specification canbe used with or instead of any feature, structure, component, material,step, or method that is described and/or illustrated in any otherembodiment in this specification. Additionally, any feature, structure,component, material, step, or method that is described and/orillustrated in one embodiment may be absent from another embodiment.

Glucose Control System Overview

A glucose control system, such as a blood glucose control system (BGCS),may be used to control a glucose level or a blood glucose level in asubject. Blood glucose control systems can include a controllerconfigured to generate dose control signals for one or more glucosecontrol agents that can be infused into the subject. Glucose controlagents include regulatory agents that tend to decrease blood glucoselevel, such as insulin and insulin analogs, and counter-regulatoryagents that tend to increase blood glucose level, such as glucagon ordextrose. A blood glucose control system configured to be used with twoor more glucose control agents can generate a dose control signal foreach of the agents. In some embodiments, a blood glucose control systemcan generate a dose control signal for an agent even though the agentmay not be available for dosing via a medicament pump connected to thesubject.

Glucose control agents can be delivered to a subject via subcutaneousinjection, via intravenous injection, or via another suitable deliverymethod. In the case of blood glucose control therapy via an ambulatorymedicament pump, subcutaneous injection is most common. An ambulatorymedicament pump (AMP) is a type of ambulatory medical device (“AMD”),which is sometimes referred to herein as an ambulatory device, anambulatory medicament device, or a mobile ambulatory device. Ambulatorymedical devices include ambulatory medicament pumps and other devicesconfigured to be carried by a subject and to deliver therapy to thesubject. Multiple AMPs are described herein. It should be understoodthat one or more of the embodiments described herein with respect to oneAMP may be applicable to one or more of the other AMPs described herein.

In some examples, the ambulatory medical device (AMD) is an electricalstimulation device, and therapy delivery includes providing electricalstimulation to a subject. An example of an electrical stimulation deviceis a cardiac pacemaker. A cardiac pacemaker generates electricalstimulation of the cardiac muscle to control heart rhythms. Anotherexample of an electrical stimulation device is a deep brain stimulatorto treat Parkinson's disease or movement disorders.

Blood Glucose Control System Overview

A blood glucose control system (BGCS) is used to control blood glucoselevel in a subject. Blood glucose control systems can include acontroller configured to generate dose control signals for one or moreglucose control agents that can be infused into the subject. Glucosecontrol agents include regulatory agents that tend to decrease bloodglucose level, such as insulin and insulin analogs, andcounter-regulatory agents that tend to increase blood glucose level,such as glucagon or dextrose. A blood glucose control system configuredto be used with two or more glucose control agents can calculate a dosecontrol signal for each of the agents. In some embodiments, a bloodglucose control system can calculate a dose control signal for an agenteven though the agent may not be available for dosing via a medicamentpump connected to the subject.

Glucose control agents can be delivered to a subject via subcutaneousinjection, via intravenous injection, or via another suitable deliverymethod. In the case of blood glucose control therapy via an ambulatorymedicament pump, subcutaneous injection is most common. An ambulatorymedicament pump 100 is a type of ambulatory medical device, which issometimes referred to herein as an ambulatory device, an ambulatorymedicament device, a mobile ambulatory device, or an AMD. Ambulatorymedical devices include ambulatory medicament pumps and other devicesconfigured to be carried by a subject and to deliver therapy to thesubject.

In some examples, the ambulatory medical device (AMD) is an electricalstimulation device, and therapy delivery includes providing electricalstimulation to a subject. An example of an electrical stimulation deviceis a cardiac pacemaker. A cardiac pacemaker generates electricalstimulation of the cardiac muscle to control heart rhythms. Anotherexample of an electrical stimulation device is a deep brain stimulatorto treat Parkinson's disease or movement disorders.

FIG. 1A-FIG. 1C show examples of blood glucose control systems thatprovide blood glucose control via an ambulatory medical device or AMD,such as a medicament pump connected to a subject. In FIG. 1A, the AMD100 (medicament pump) is connected to an infusion site 102 using aninfusion set 104. The AMD 100 (medicament pump) has integrated pumpcontrols 106 a that permit a user to view pump data and change therapysettings via user interaction with the pump controls 106 a. A glucoselevel sensor 110 generates a glucose level signal that is received bythe blood glucose control system.

In FIG. 1B, the medicament pump 100 communicates with an externalelectronic device 108 (such as, for example, a smartphone) via awireless data connection. At least some of the pump controls 106 a and106 b can be manipulated via user interaction with user interfaceelements of the external electronic device 108. The glucose level sensor110 can also communicate with the AMD 100 (medicament pump) via awireless data connection.

In FIG. 1C, the AMD 100 (medicament pump) includes an integrated cannulathat inserts into the infusion site 102 without a separate infusion set.At least some of the pump controls 106 b can be manipulated via userinteraction with user interface elements of an external electronicdevice 108. In some instances, pump controls can be manipulated via userinteraction with user interface elements generated by a remote computingenvironment (not shown), such as, for example, a cloud computingservice, that connects to the AMD 100 (medicament pump) via a direct orindirect electronic data connection.

Glucose control systems typically include a user interface configured toprovide one or more of therapy information, glucose level information,and/or therapy control elements capable of changing therapy settings viauser interaction with interface controls. The user interface can beimplemented via an electronic device that includes a display and one ormore buttons, switches, dials, capacitive touch interfaces, ortouchscreen interfaces. In some embodiments, at least a portion of theuser interface is integrated with an ambulatory medicament pump that canbe tethered to a body of a subject via an infusion set configured tofacilitate subcutaneous injection of one or more glucose control agents.In certain embodiments, at least a portion of the user interface isimplemented via an electronic device separate from the ambulatorymedicament pump, such as a smartphone.

FIG. 2A-FIG. 2D illustrate block diagrams showing example configurationsof a glucose control system 200 a/200 b/200 c/200 d. As shown in FIG.2A, a glucose control system 200 a can include a controller 202 a havinga hardware or an electronic processor 204 a and a memory 210 a thatstores instructions 208 a executable by the electronic processor 204 a.The controller 202 a and a pump 212 can be integrated into an ambulatorymedical device (AMD) 100. The AMD 100 can have one or more pumps 212.The AMD 100 can include a transceiver 214 a transceiver or wirelesselectronic communications interface 214 a for wireless digital datacommunications with external electronic devices. When the instructions208 a stored in memory 210 a are executed by the electronic processor204 a, the controller 202 a can implement at least a portion of acontrol algorithm that generates dose control signals for one or moreglucose control agents based on time-varying glucose levels of thesubject (e.g., received from a glucose level sensor 110 that is incommunication with the AMD 100, e.g., a medicament pump) and one or morecontrol parameters. The dose control signals, when delivered to the pump212, result in dosing operations that control the blood glucose of asubject. The pump 212 may be controlled by a pump controller. The pumpcontroller receives the dose control signals and controls the operationof the pump 212 based on the received dose control signals. In someembodiments the pump controller may be integrated with the pump.

As shown in FIG. 2B, a glucose control system 200 b can operate at leastpartially via execution of instructions 208 b by an electronic processor204 b of an external electronic device 108 separate from the AMD 100.The external electronic device 108 can include a transceiver 214 bcapable of establishing a wireless digital data connection to the AMD100, and a controller 202 b can implement at least a portion of acontrol algorithm via execution of instructions 208 b stored in memory210 b. When the instructions 208 b stored in memory 210 b are executedby the electronic processor 204 b, the controller 202 b can implement atleast a portion of a control algorithm that generates dose controlsignals for one or more glucose control agents based on time-varyingglucose levels of the subject and one or more control parameters. Thedose control signals, when delivered to the pump controller of the pump212, result in dosing operations that control the blood glucose of asubject. In some embodiments, the dose control signals are transmittedfrom the device transceiver 214 b to the AMD transceiver 214 a over ashort-range wireless data connection 216. The AMD 100 receives the dosecontrol signals and passes them to the pump 212 for dosing operations.

As shown in FIG. 2C, a glucose control system 200 c can operate at leastpartially via execution of instructions 208 c on an electronic processor204 c integrated with a remote computer 206, such as, for example, acloud service. When the instructions 208 c stored in memory 210 c areexecuted by the electronic processor 204 c, the controller 202 c canimplement at least a portion of a control algorithm that generates dosecontrol signals for one or more glucose control agents based ontime-varying glucose levels of the subject and one or more controlparameters. The dose control signals, when delivered to the pump 212,result in dosing operations that control the blood glucose of a subject.In some embodiments, the dose control signals are transmitted from theremote computer WAN connection interface 220 c to the AMD WAN connectioninterface 220 a over an end-to-end wireless data connection 218. The AMD100 receives the dose control signals and passes them to the pump 212for dosing operations.

As shown in FIG. 2D, a glucose control system 200 d can have two or morecontrollers 202 a, 202 b, 202 c that cooperate to generate a dosecontrol signal for dosing operations by the pump 212. A remote computer206 can transmit or receive data or instructions passed through a WANconnection interface 220 c via an end-to-end wireless data connection218 to a WAN connection interface 220 b of an external electronic device108. The external electronic device 108 can transmit or receive data orinstructions passed through a transceiver 214 b via a short-rangewireless data connection 216 to a transceiver 214 a of an AMD 100. Insome embodiments, the electronic device can be omitted, and thecontrollers 202 a, 202 c of the AMD 100 and the remote computer 206cooperate to generate dose control signals that are passed to the pump212. In such embodiments, the AMD 100 may have its own WAN connectioninterface 220 a to support a direct end-to-end wireless data connectionto the remote computer 206.

As shown in FIG. 3, in some embodiments, the glucose control system 200a includes circuitry that implements an electronic communicationsinterface (ECI) 302 configured to send and receive electronic data fromone or more electronic devices. The ECI includes a sensor interface 304configured to receive a glucose level signal from a glucose level sensor110 such as a continuous glucose monitor (CGM). Some CGMs generate theglucose level signal at fixed measurement intervals, such as five-minuteintervals. The glucose level sensor 110 can be operatively connected toa subject in order to generate a glucose level signal that correspondsto a blood glucose estimate or measurement of the subject. The glucoselevel signal can be used by the controller 202 a to generate a dosecontrol signal. The dose control signal can be provided to a pump 212via a pump interface 306. In some embodiments, the sensor interface 304connects to the glucose level sensor 110 via a short-range wirelessconnection 308. In some embodiments, the pump interface 306 connects tothe pump 212 via a short-range wireless connection 310. In otherembodiments, the pump interface 306 connects to the pump 212 via a localdata bus, such as when the controller 202 a, the ECI 302, and the pump212 are integrated into an AMD 100.

The controller can be configured to generate the dose control signalusing a control algorithm that generates at least one of a basal dose, acorrection dose, and/or a meal dose. Examples of control algorithms thatcan be used to generate these doses are disclosed in U.S. PatentApplication Publication Nos. 2008/0208113, 2013/0245547, 2016/0331898,and 2018/0220942 (referenced herein as the “Controller Disclosures”),the entire contents of which are incorporated by reference herein andmade a part of this specification. The correction dose can includeregulatory or counter-regulatory agent and can be generated using amodel-predictive control (MPC) algorithm such as the one disclosed inthe Controller Disclosures. The basal dose can include regulatory agentand can be generated using a basal control algorithm such as disclosedin the Controller Disclosures. The meal dose can include regulatoryagent and can be generated using a meal control algorithm such asdisclosed in the Controller Disclosures. Additional aspects andimprovements for at least some of these controllers are disclosedherein. The dose control signal can be transmitted to an infusion motorvia the ECI 302 or can be transmitted to the infusion motor via anelectrical conductor when the controller 202 a is integrated in the samehousing as the infusion motor.

As shown in FIG. 4A, the controller 400 can be configured to operate in“online mode” during time periods when the controller receives a glucoselevel signal 402 from a glucose level sensor 110. In online mode, thecontrol algorithm generates a dose control signal 404 that implementsregular correction doses based on values of the glucose level signal 402and control parameters of the control algorithm. The pump 212 isconfigured to deliver at least correction doses and basal doses to thesubject without substantial user intervention while the controller 400remains in online mode.

As shown in FIG. 4B, the controller 400 can be configured to operate in“offline mode” during time periods when the controller does not receivea glucose level signal 402 from a sensor 110, at least during periodswhen the glucose level signal 402 is expected but not received. Inoffline mode, the control algorithm generates a dose control signal 404that implements correction doses in response to isolated glucosemeasurements 406 (such as, for example, measurements obtained from thesubject using glucose test strips) and based on control parameters ofthe control algorithm. The pump 212 is configured to deliver basal dosesto the subject without substantial user intervention and can delivercorrection doses to the subject in response to isolated glucosemeasurements 406 while the controller 400 remains in offline mode.

Example Ambulatory Medical Device

In some embodiments, the ambulatory medicament device (AMD) can be aportable or wearable device such as an ambulatory medicament pump (AMP)that provides life-saving treatment to a subject or subjects bydelivering one or more medicaments (e.g., insulin and/or glucagon) to asubject or subjects. In some cases, the AMD includes an AMP along withother systems, such as a glucose control system and/or transceiver. SomeAMDs may continuously monitor the health condition of a subject using asensor and deliver therapy such as one or more medicaments based on thehealth condition of the subject. For example, an ambulatory medicamentpump (e.g., an insulin pump or a bi-hormonal pump) may monitor the bloodglucose level in a subject using a Continuous Glucose Monitor (CGM) andadjust the dose or frequency of the medicament delivery (e.g., insulinor glucagon) accordingly. Certain ambulatory medicament devices may beworn by subjects constantly (e.g., all day), or for a large portion ofthe day (e.g., during waking hours, during sleep hours, when notswimming, etc.) to enable continuous monitoring of the health conditionof the subject and to deliver medicament as necessary.

FIG. 5A illustrates a three-dimensional (3D) view of an exampleambulatory medical device 500 (such as an ambulatory medicament pump)comprising a housing 502 with a wake button 506 and a touchscreendisplay 504. FIG. 5B is an illustration of a cross sectional view of theambulatory medical device 500 shown in FIG. 5A. In this example, all theelectronic modules 508 are included inside the housing, for example, asa single integrated electronic board. The wake button 506 may be anytype of button (e.g., capacitive, mechanical) that registers an inputgenerated by user interaction with the wake button 506 to generate awake signal. In some embodiments, the wake signal is generated by asensor (e.g., a biometric sensor such as a fingerprint reader or aretinal scanner, an optical or RF proximity sensor, and the like). Invarious embodiments, the wake signal may be generated by userinteraction with the touch screen display 504 or with an alphanumericpad (not shown). In some other examples, wake signal may be generatedbased on facial recognition or other biometric indicia. In yet otherexamples, the wake signal may be generated by a wireless signal such asRFID or Bluetooth signals or by detection of movement using one or moremotion sensors such as an accelerometer. The wake button 506, iftouched, pressed, or held for a certain period of time, may generate awake signal that activates the touchscreen display 504. In someexamples, touches on the touchscreen display 504 are not registereduntil the wake button activates the touchscreen display. In some suchexamples, the AMD remains locked from accepting at least certain typesof user interaction or settings modification until a gesture (such as,for example, any of the gesture interactions described with reference toany of the embodiments disclosed herein) is received after thetouchscreen display 504 is activated by the wake button 506. In someexamples, after the touchscreen display 504 has been activated by thewake signal, a passcode may be required to unlock the touchscreendisplay. In some embodiments, the wake signal is generated by a sensor(e.g., a biometric sensor such as a fingerprint reader or a retinalscanner, an optical or RF proximity sensor, and the like). In variousembodiments, the wake signal may be generated by user interaction withthe touchscreen display 504 or with an alphanumeric pad (not shown). Insome examples, a wake signal may be generated based on facialrecognition or other biometric indicia. In some examples, the wakesignal may be generated by a wireless signal such as a signal generatedby an RFID system or Bluetooth signals received from an electronicdevice or by detection of movement using one or more motion sensors suchas an accelerometer.

FIG. 6 illustrates different systems and sub-systems that may beincluded in an example AMP 600 (e.g., a blood glucose control system).As mentioned above, in some examples, the AMP may comprise glucosecontrol system, such as a complete blood glucose control system.Further, in some cases, the AMP 600 may be an AMD that includes amedicament pump. In some implementations, the AMP may include systemsand sub-systems that can enable monitoring a subject's blood glucoselevel, managing the subject's diabetes, tracking a condition of the AMP600, and/or communicating with one or more computing systems. Forexample, the AMP 600 may include a mono-hormonal or bi-hormonalmedicament pump configured to administer one or more types of insulinand, in some cases, counter-regulatory agent (e.g., glucagon or othermedicaments that can reduce or address hypoglycemia). As anotherexample, the AMP 600 may include one or more alarm generators,transceivers, touchscreen controllers, display controllers, encryptionsub-systems, etc. In some examples, two or more of the systems may beintegrated together inside a single housing 502 (as shown in FIG. 5A andFIG. 5B). In some examples, one or more systems or sub-systems may beindividual modules contained in separate housings that can communicatewith other systems and/or the main unit via a wired or wirelesscommunication link (e.g., Bluetooth®). The AMP 600 may include acommunication system 622, a medicament delivery system 612, a userinterface system 616, and a controller 602 (or control system). In someembodiments, one or more systems may comprise one or more single purposeor multipurpose electronic sub-systems. In some such examples, one ormore electronic sub-systems may perform procedures associated withdifferent features of the AMP 600. In some other embodiments, one ormore systems or sub-systems may comprise a non-transitory memory thatcan store machine readable instructions and a processor that executesthe instructions stored in the memory. The memory may be a non-volatilememory, such as flash memory, a hard disk, magnetic disk memory, opticaldisk memory, or any other type of non-volatile memory. Further, types ofmemory may include but are not limited to random access memory (“RAM”)and read-only memory (“ROM”). In some such examples, a system can beprogramed to perform different procedures each implemented based on adifferent set of instructions.

The controller 602 may include one or more processors 604, a memory 610that may comprise one or more non-transitory and/or non-volatilememories and an interface 606 that enables data and signal communicationbetween the controller 602 and other systems of the AMP (e.g.,communication system 622, medicament delivery system 612 or userinterface system 616). The memory 610 may be divided into two or morememory segments. The main memory 610 may exchange data with sub-systemswithin the controller 602 as well as other systems (e.g., via theinterface 606). The memory 610 may store data while the controller 602is powered or unpowered. The processor 604 may be any type ofgeneral-purpose central processing unit (“CPU”). In some embodiments,the controller may include more than one processor of any typeincluding, but not limited to complex programmable logic devices(“CPLDs”), field programmable gate arrays (“FPGAs”),application-specific integrated circuits (“ASICs”) or the like. Theinterface 606 may include data transfer buses and electronic circuitsconfigured to support data exchange among different sub-systems withinthe controller 602. In some examples, in addition to data exchangebetween any of the systems and the controller 602, the interface 606 maysupport data and signal exchange among other systems of the AMP 600.

The interface 606 may include a plurality of interconnected electronicmodules for signal conditioning and signal conversion (e.g., A-to-D orADC conversion and D-to-A conversion or DAC conversion) configured tosupport communication and data exchange between different systems. Forexample, the interface 606 may convert an analog signal received fromthe communication system 622 and convert it to a digital signal that canbe processed by the controller 602. As another example, the interface606 may receive a digital control signal and convert it to a dose signal(e.g., an analog signal) that can be transmitted to the medicamentdelivery system 612, for example, to control one or more infusion pumpsincluded in the medicament delivery system 612.

In some embodiments, the medicament delivery system 612 may comprise oneor more infusion pumps configured to deliver one or more medicaments(e.g., insulin or glucagon) to a subject 620 and a pump controller thatmay activate the infusion pumps upon receiving does control signals. Insome examples, the medicaments may be stored in one or more medicamentcartridges that may be housed in or inserted into the medicamentdelivery system 612. In some examples, the medicament delivery system612 may include electronic and mechanical components configured tocontrol an infusion pumps based on signals received from controller 602(e.g., via the interface 606).

The user interface system 616 may include a display to show statusinformation about the AMP 600 and/or medicament. For example, the statusinformation may include medicament type, delivery schedule, softwarestatus, and the like. The display may show graphical images and textusing any display technology including, but not limited to OLED, LCD, ore-ink. In some embodiments, the AMP 600, may include a user interface(e.g., an alphanumeric pad) that lets a user provide information orinteract with the AMP 600 to modify the settings of the AMP 600, respondto request for certain actions (e.g., installing a software) and thelike. The alphanumeric pad may include a multitude of keys withnumerical, alphabetical, and symbol characters. In differentembodiments, the keys of the alphanumeric pad may be capacitive ormechanical. The user may be a subject 620 receiving medicament ortherapy, or may be an authorized user, such as a clinician or healthcareprovider, or a parent or guardian of the subject 620. In some otherembodiments, the AMP 600 may include a touchscreen display that producesoutput and accepts input enabling a two-way interaction between the userand the AMP 600. The touchscreen display may be any input surface thatshows graphic images and text and registers the position of touches onthe input surface. The touchscreen display may accept input viacapacitive touch, resistive touch, or other touch technology. The inputsurface of the touchscreen display can register the position of toucheson the surface. In some examples, the touchscreen display can registermultiple touches at once. In some embodiments, the keypad may be adisplay of a keypad. For example, an alphanumeric pad comprisinguser-selectable letters, numbers, and symbols may be displayed on thetouchscreen display. In some examples, the touchscreen may present oneor more user-interface screens to a user enabling the user to modify oneor more therapy settings of the ambulatory medicament device.

In some examples, a user-interface screen may comprise one or moretherapy change control elements (e.g., displayed on the touchscreendisplay) enabling a user or the subject to access therapy changecontrols and modify therapy settings by interacting with these controlelements. For example, the user can modify the therapy settings bychanging one or more control parameters using the corresponding therapychange control elements. In some embodiments, a therapy controlparameter may be any parameter that controls or affects the volume,duration and/or the frequency of medicament doses delivered to thesubject.

In some embodiments the communication system 622 may include one or moredigital data interfaces to send or receive digital data via a wired or awireless link. For example, the communication system may include one ormore wireless transceivers, one or more antennas, and/or one or moreelectronic systems (e.g., front end modules, antenna switch modules,digital signal processors, power amplifier modules, etc.) that supportcommunication over one or more communication links and/or networks. Insome examples, each transceiver may be configured to receive or transmitdifferent types of signals based on different wireless standards via theantenna (e.g., an antenna chip). Some transceivers may supportcommunication using a low power wide area network (LPWAN) communicationstandard. In some examples, one or more transceivers may supportcommunication with wide area networks (WANs) such as a cellular networktransceiver that enables 3G, 4G, 4G-LTE, or 5G. Further, one or moretransceivers may support communication via a Narrowband Long-TermEvolution (NB-LTE), a Narrowband Internet-of-Things (NB-IoT), or aLong-Term Evolution Machine Type Communication (LTE-MTC) communicationconnection with the wireless wide area network. In some cases, one ormore transceivers may support Wi-Fi® communication. In some cases, oneor more transceivers may support data communication via a Blue tooth orBlue tooth Low Energy (BLE) standard. In some examples, one or moretransceivers may be capable of down-converting and/or up-converting abaseband or data signal from and/or to a wireless carrier signal. Insome examples, the communication system 622 may wirelessly exchange databetween other components of the AMP 600 (e.g., a blood glucose levelsensor), a mobile device (e.g., smart phone, a laptop and the like), aWi-Fi network, WLAN, a wireless router, a cellular tower, a Bluetoothdevice and the like. The antenna may be capable of sending and receivingvarious types of wireless signals including, but not limited to,Bluetooth, LTE, or 3G.

In some examples, the communication system 622 may support directend-to-end communication between the AMP 600 and a server or a cloudnetwork. In some examples the AMP 600 may communicate with anintermediary device (e.g., a smart phone or other mobile devices, apersonal computer, a notebook, and the like). In some embodiments, theAMP 600 may include an eSIM card that stores information that may beused to identify and authenticate a mobile subscriber. The eSIM card mayenable the AMP 600 to function as an Internet of Things (IoT) devicethat can communicate over a network that supports communication with IoTdevices. In other embodiments, the AMP 600 may be configured to transmitdata using a narrowband communication protocol such as 2G or EDGE. Usingthe cellular connection, the AMP 600 may be paired with a mobile deviceat inception and permit real-time data access to the AMP 600 by ahealthcare provider. In certain implementations, the AMP 600 may includea geolocation receiver or transceiver, such as a global positioningsystem (GPS) receiver. As previously stated, each of the AMPs describedherein may include one or more of the embodiments described with respectto the other AMPs unless specifically stated otherwise. In someembodiments the communication system 622 may include a Near FieldCommunication (NFC) sub-system that enables contactless data exchangebetween the AMP 600 and an electronic device located in the vicinity ofthe AMP 600.

Example Operation of the AMP

In some embodiments, the AMP 600 may continuously, periodically, orintermittently receive data related to a health condition of the subject(e.g., blood glucose level, blood glucose trend, heart rate, bodymovement indicia, etc.). This information may be encoded to a signalprovided to AMP 600 by a sensor 618. In some such embodiments, thesensor 618 can be a continuous glucose monitor (CGM) that is connectedto the AMP 600 via a wired or wireless link (e.g., a link based on orimplementing the Bluetooth® standard). In some examples, a CGM may be awearable biomedical sensor that measures a blood glucose level in theinterstitial fluid. In some examples, the signal sent by the sensor 618may be received by the communication system 622 and transmitted to thecontroller 602 where the signal may be analyzed to determine whether todeliver medicament to the subject 620. In some examples, a secondcommunication system may be included in the AMP 600 to communicate withthe sensor 618. If it is determined that medicament should beadministered to the subject, the controller 602 may determine the dosageand/or type of medicament to administer to the subject. Thedetermination of medicament dosage and/or type may be based at least inpart on the information received from the sensor 618. The controller 602may generate a dose control signal and send the dose control signal tothe medicament delivery system 612 to initiate medicament delivery tothe subject. In some examples, the dose control signal may be receivedby a pump controller that controls operation of an infusion pump.

In some embodiments, the controller 602 may perform one or moreprocedures using the processor 604 (or a plurality of processors) thatexecute instructions 608 stored in the memory 610 of the controller 602.These procedures may include, but are not limited to, determining theneed for delivering medicament, determining the type of medicamentand/or a dose size of medicament, determining the rate of deliveryduring a therapy session, providing information (e.g., device status,next delivery time, level of certain analytes in the subject's blood,and the like) via the user interface system 616, processing the datareceived from the sensor 618, or managing access to control parameters(e.g., by controlling one or more therapy change controls that may beprovided by the user interface system 616).

In some embodiments, the AMP 600 may deliver multiple types of therapy.The type of therapy to be delivered may be determined automatically bythe controller 602 or may be selected by the user. For example, the AMP600 may deliver the therapy of infusing insulin into a user and may alsodeliver glucagon into the user. In some examples, the user interfacesystem 616 may allow the user to select the type of medicament infusedto the subject 620 during therapy (e.g., insulin, glucagon or both). Inother embodiments, other hormones, medicaments, or therapies may bedelivered. In some examples, the controller 602, may determine the typeof medicament that is delivered to the subject 620 base at least in parton the data received from the communication system 622.

Communication and Networking

FIG. 7 illustrates various methods, and data links or communicationpaths that AMP 600 may use to communicate (e.g., exchange digital data)with an electronic device 702. The communication may include obtainingapplication updates, sending and/or receiving therapy data and/ortherapy reports, receiving passcodes or access codes, sending a request(e.g., request for a safe access level or a request for a therapyreport), receiving values of control parameters, and the like. Theelectronic device 702 can be a cloud server 708, a mobile phone 706(e.g., a mobile phone of a user, the subject 620, a physician, and thelike), or a personal computer 704 (e.g., a laptop, desktop, tablet, etc.of a user, the subject 620, a physician, and the like). In someexamples, the cloud server 708 may be part of a data center (e.g., thedata center of a healthcare provider). Further, the electronic device102 may includes other types of devices, such as smartglasses,smartwatches, etc.

In some embodiments, the AMP 600 may establish a connection (e.g., usingthe communication system 622) with the electronic device 702 through anintermediary device 710 (e.g., a smart phone or other mobile device, apersonal computer, a notebook or the like). In some examples, the AMP600 may communicate with the electronic device 702 through a local areanetwork 712 (LAN) and/or through a Wi-Fi connection. Alternatively, orin addition, the AMP 600 may establish a communication connection to theelectronic device 702 via a wide area network 716 (WAN). In someexamples, the communication between the AMP 600 medical device and theelectronic device may be encrypted.

In some embodiments, the AMP 600 may establish a direct end-to-endcommunication connection over a wide area network 716 (e.g., a cellularnetwork) with the electronic device 702. In some cases, adirect-end-to-end communication connection may be a connection that doesnot involve a local device, a device that is accessible by the user orthe subject (besides the AMP 600), a Wi-Fi network, a short rangewireless link (e.g., Bluetooth), or the like. In some such cases, thedirect end-to-end communication may pass through one or more wirelesssystems (e.g., receivers, transmitters, transceivers, or antenna) of awide area network 716. In some examples, the electronic device 702 mayestablish the end-to-end connection by receiving a public key from theAMP 600. In some examples, the public key and a private key stored inthe electronic device 702 can be used to permit the electronic device702 to decrypt data transmitted by the AMP 600. In some implementations,the electronic device 702 may establish a direct end-to-end dataconnection with the AMP 600 based on receiving a device identifierassociated with the AMP 600. The device identifier may be a uniqueidentifier specific to the AMP 600. In some other implementations,establishing the direct end-to-end data connection may includedetermining that the AMP 600 is permitted to communicate with theelectronic device 702 based at least in part on the device identifier.In some examples, the device identifier may be initially provided toelectronic device 702 prior to provisioning of the AMP 600 to thesubject. For example, the device identifier may be initially provided tothe networked-computing environment as part of a manufacturing processfor manufacturing the AMP 600. In some examples, the device identifiermay include or may be based on one or more of an Internet Protocol (IP)address, a Media Access Control (MAC) address, a serial number, or asubject identifier of a subject that receives therapy from the AMP 600.In some cases, the subject or a user may establish or initiateestablishing the direct end-to-end data connection with the electronicdevice 702. In some cases, the direct end-to-end data connection may beinitiated or established without any action by the subject or the user.For example, the direct end-to-end data connection may be establishedautomatically at particular times and/or when the AMP 600 is in aparticular location. In some such cases, this automatic connection mayoccur using information supplied to the AMP 600 at a time ofmanufacture, shipment, sale, or prescription to the subject.Alternatively, or in addition, a subject or other user may configure theAMP 600 to automatically connect to the electronic device 702 atparticular times and/or locations. In some cases, the wide area networkmay include, or may communicate with, the Internet 714.

In some embodiments, the AMP 600 may be configured to communicate viathe wide area network 716 during manufacture or prior to beingprovisioned to the subject. For example, a manufacturer can register theAMP 600 with a wireless wide-area network provider (e.g., T-Mobile orVerizon) and provide an International Mobile Equipment Identity (IMEI)number or serial number for the AMP 600 to the network provider.Moreover, fees can be negotiated between the manufacturer and thenetwork provider or between the subject's health insurance and thenetwork provider. Similarly, fees may be paid by the manufacturer orhealth insurance provider, or other entity, without subject involvement.Thus, the subject's AMP 600 may be configured to communicate via thenetwork of the network provider without any action by the subject or theuser. In some cases, the subject may be responsible for obtainingwireless service to connect the AMP 600 to a wide area network 716(e.g., a cellular network).

In some examples, the AMP 600 may be pre-registered or authenticatedwith a computing network of the cloud services provider as part of themanufacturing process or before AMP 600 is provided to the subject. Thisenables the AMP 600 to communicate over the wide area network with thecomputing system of the cloud services provider from day one without anyor with minimal configuration by the subject. In some cases, a user,such as a healthcare provider may register or associate the AMP 600 withthe subject at the computing network of the cloud services provider.

In some embodiments, the AMP 600 may use a whitelist, or approved list,that identifies via a unique identifier (e.g., via an IP address, a MACaddress, or a URL) one or more permitted cloud servers 708 or computingsystems of the cloud computing system that the AMP 600 is permitted toaccess. By restricting access to an approved set of computing systems,the risk of malicious actors accessing the AMP 600 is reduced. Moreover,in some cases, the AMP 600 may include a blacklist, or restricted list,that identifies systems the AMP 600 is not permitted to access. Theblacklist may be updated as more restricted or unsafe websites, networkaccessible systems, or computing systems are identified. Similarly, thewhitelist may be updated over time if approved systems are added orremoved.

Further, the cloud computing service may have a whitelist, or approvedlist, that uses unique identifiers to specify AMP 600 and/or othercomputing systems (e.g., remote display systems) that are permitted tocommunicate with the cloud computing system. Moreover, as with the AMP600, the cloud computing service may have a blacklist or restricted listthat identifies AMPs, or other computing devices, that are not permittedto access the cloud computing services. An AMP 600 may be added to therestricted list if it is decommissioned, damaged, or is no longer inpossession of the subject. It may be desirable to remove an AMP's accessto the cloud computing service to help protect private or personal dataof a subject. Advantageously, establishing a connection based on awhitelist may enhance the security of the communication link establishedbetween AMP 600 and the cloud server 708 or other computing systems. Inaddition to the identifiers that identify permitted computing systemsfor access by the AMP 600 and/or permitted AMPs for access by a cloud ornetworked computing service, the whitelist may include any informationthat may facilitate access to the systems identified on the whitelist.For example, the whitelist may include access information (e.g.,usernames, passwords, access codes, account identifiers, portidentifiers, a shared secret, public keys, etc.). It should beunderstood that the whitelist may include different informationdepending on whether the whitelist is publicly accessible, accessible byonly the AMP, accessible by authorized users or devices, etc. Forexample, a publicly accessible whitelist or a whitelist accessible bymore than one authorized system or user may not include passwords oraccess codes.

In some cases, the AMP 600 may use a whitelist that identifies via, forexample, a unique identifier (e.g., via an IP address, a MAC address, ora URL) permitted cloud servers or computing systems. In some examples,the electronic device 702 may have a whitelist that uses uniqueidentifiers to specify AMP 600 and/or other computing systems (e.g.,remote display systems) that are permitted to communicate with theelectronic device 702. The whitelist may be stored in a memory of AMP600 and/or in a memory of a trusted computing device that is accessibleby the AMP 600. The trusted computing device can include any computingdevice that a manufacturer of the AMP 600 has identified as trusted.Alternatively, or in addition, the trusted computing device can includeany computing device that a subject or user that care for the subject(e.g., parent, guardian, or healthcare provider) has identified as atrusted computing device that is designated to store the whitelist. Insome examples, the whitelist may be configured during manufacture of theAMP 600. For example, the whitelist may be configured with connectioninformation to establish communication with one or more computingsystems of a networked-computing environment. In some examples, the AMP600 may be configured to execute the specific computer-executableinstructions to at least obtain an address of a computing system fromthe whitelist and to establish a direct end-to-end data connection tothe computing (e.g., a computing system in the networked-computingenvironment), via a wireless wide area network using the address. Insome embodiments, the AMP 600 may be configured to execute the specificcomputer-executable instructions to at least receive a public key fromthe computing system of the networked-computing environment.

In some embodiments, a portion of the communication system 622 of theAMP 600 may be enabled or disabled by the controller 602. In some cases,upon receiving a trigger, the controller 602 may maintain wireless datacommunication between the AMP 600 and the sensor 618 but disablewireless communication with all other electronic devices. In someexamples, the trigger can be a signal received from the user interfacesystem 616 indicating a user interaction with a user interface (e.g., atouchscreen display). For example, a user interface element may beprovided on a touchscreen display to activate an “airplane mode.” Insome embodiments, the trigger may be a signal received from a locationsensor. For example, the controller may automatically disable wirelesscommunication signals that are not associated with the sensor 618, uponreceiving a location signal from a location sensor (e.g., a GPS)indicating that the user is an airplane.

In some embodiments, the controller 602 may switch on one or morewireless communication sub-systems of the communication system 622 upondetermining that a condition is satisfied by the therapy data (e.g.,glucose level received from the sensor 618). In some embodiments, thecontroller 602 may switch on one or more wireless communicationsub-systems of the communication system 622 based on a location of theuser or the subject determined by a location sensor.

In some embodiments, one or more settings of the AMP 600 can be storedin an electronic device automatically or upon receiving a request from auser. For example, using a user interface of the AMP 600, the user maysend a request to save one or more settings of the AMP 600 in a remoteelectronic device (e.g., a cloud server) via a wireless digital datalink. As another examples, the AMP 600 may automatically store itscurrent settings in a remote electronic device (e.g., a cloud server),by establishing wireless data connection with the remote electronicdevice. In some examples, a user may provide instructions to the AMP 600(e.g., via user interface or a wireless link), so that the AMP 600periodically (e.g., every week, every month) stores one or more settingsof the AMP 600 in a remote electronic device.

In some embodiments, a one-time passcode may be provided to the user orthe subject to enable connecting the AMP 600 to a remote electronicdevice (e.g., a cloud server), in order to download a device state tothe AMP 600. For example, when a user obtains a new AMP, the user dataand customized settings, which were previously stored in the remoteelectronic device, may be downloaded to the new AMP. The onetime passcode can be requested from a computer or a mobile phone, for example,using an application program configured to “set up a pump”.

In some cases, the new AMP may be provided to the user with limitedfunctionality (e.g., the pump motor may not be enabled) while theprescription verification process is proceeding. Once the prescriptionis verified, the required functionalities and settings associated withprescription, may be enabled.

In some, examples the eligibility of a user for downloading the personaldata and/or the AMP state (e.g., therapy settings) may be confirmedbased on the AMP's serial number.

Modifying Therapy Settings

In some embodiments, AMP 600 may allow a user or the subject 620, tomodify a therapy setting of the AMP 600. The therapy setting maycomprise values or selections related to one or more control parametersthat control the dose control signal generate by the controller 602. Forexample, the AMP 600 may provide one or more therapy change controls ina user interface that may receive a user inputs 614 to modify one ormore control parameters of the AMP 600. In some embodiments, the therapychange controls can be therapy change control elements provided in atherapy change user interface (e.g., a touchscreen display) and the userinput 614 can be received in response to a user interaction with atherapy change control element.

In certain embodiments, the user may wake the AMP 600 from a sleep stateor unlock the AMP 600 by, for example, interacting with a wakeinterface. When the AMP 600 is in a sleep state, the user interface maynot receive the user input 614 or user input signals corresponding touser input. Waking the AMP 600 may include activating a touchscreeninterface or presenting a lock screen to a user. Further, waking the AMP600 may include waking the touchscreen controller such that it canreceive user input or user input signals corresponding to user input.The wake interface can include one or more of the additional userinterfaces mentioned above that are configured to generate and provide awake input (or wake signal) to the controller 602 when detecting apre-set user interaction. Alternatively, or in addition, the wakeinterface can be any type of wake interface element of the AMP 600 thata user can interact with to wake at least a feature (e.g., a touchscreeninterface) of the AMP 600. For example, the wake interface element canbe a physical button (e.g., a push button, a slide button, etc.), acapacitive element, a resistive element, or an inductive element. Insome cases, the wake interface element can be or can include a biometricelement, such as a fingerprint reader, an iris scanner, a face detectionscanner, etc. In some cases, the AMP 600 may wake in response todetection of a movement or motion. For example, a determination that theambulatory medicament device is being moved with a particular motion orwithin a line of sight or a visual range of a user may cause the AMP 600to awaken or cause the AMP to awake the touchscreen interface of the AMP600. The AMP 600 may determine that the AMP 600 is being moved within aline of sight of the user based on the type of motion and/or thedetection of a user's eyes via, for example, an iris scanner or acamera.

In some examples, the user input 614 can be an input provided by thesubject 620 to change a therapy that is currently being delivered to thesubject 620. For example, the user input 614 may cause the insulin orglucagon infusion pump to start infusing an amount of insulin orglucagon into the 618. In some examples, the user input 614 provided bythe user 620, may affect the therapy delivery at future time. In someexamples, the user input may modify the rate of insulin or glucagoninfusion into the user 620. The user input 614 may also cancel insulinor glucagon infusion into the user 620 from the insulin or glucagoninfusion pump. In some cases, the user input 614 is a request to changea control parameter. The control parameter may be changed in response tothe request. Alternatively, or in addition, a confirmation action (e.g.,a swipe gesture or an interaction with a physical or digital button onthe touchscreen) confirming the requested control parameter change maybe required before the control parameter is changed.

In some cases, when a wake action is detected by the wake interface, awake input is sent to the controller 602, which may imitate or perform awake control procedure to wake/unlock the user interface (e.g., atouchscreen display). In some cases, the controller 602 may use the wakecontroller to perform the wake procedure.

When in the wake and/or unlocked state, a user may interact with atouchscreen display, alphanumeric pad or other types of user interfacesthat may be provided by user interface system 616 in a the userinterface, to obtain access to therapy change user interface.

The therapy change user interface may be activated by a first userinteraction with the user interface (e.g., touchscreen display). Whenthe first user interaction is detected, the user interface system 616may send an input signal to the controller 602 to determine if the firstuser interaction relates to a therapy change request or a controlparameter change request. In some cases, the controller 602 maydetermine whether the first user interaction corresponds to a request tochange a control parameter, or a request to access a control parameterchange interface. If it is determined that the first user interactionsatisfies a set of predefined conditions, the controller 602 may send asignal to the user interface system 616 to activate the therapy changeuser interface.

In some embodiments, the type of therapy change user interface and/orthe available therapy change selections included in the user interfacemay depend on the user interaction. For example, in response to one oftwo (or more) user interactions, the controller 602 may send one of two(or more) signals to the user interface system 616. The therapy changeuser interface may unlock one of two (or more) different therapy changeuser interfaces that may result in different options of therapy changeselections for the subject 620. In an implementation of this example, atherapy change selection to make a significant therapy change, such asdramatically (e.g., more than a magnitude, or more than 3 changeincrements) increase the rate of insulin or glucagon infusion rate, mayrequire a user interaction that is different from the user interactionthat may be required for an insulin or glucagon infusion at a normal orprescribed rate, or a smaller change to the control parameter. In someexamples, the user interaction may be a simple interaction (e.g., asimple gesture or unlock gesture interaction) that unlocks a therapychange user interface with therapy change selections that are limited inmagnitude size. Another user interaction may be a complicatedinteraction (e.g., a series of complex gestures) that unlocks a therapychange user interface with therapy change selections that have nolimits. An example of this implementation may be useful for child users.The child user may perform the first or simpler gesture that is made upof a series of simple inputs to unlock therapy change selections thatare limited. An adult user may perform the second or more complexgesture that is made up of a series of complex inputs to unlock thetherapy change user interface with therapy change selections that haveno limits. In some cases, a simple interaction may include aninteraction that is capable of being performed by a person below aparticular age (e.g., a child), above a particular age (e.g., a seniorcitizen), or associated with a particular level of maturity orintelligence (e.g., a child or an individual with a learningdisability). In contrast, a complex interaction may include aninteraction that can be performed by an average adult or person that isabove a particular minimum age (e.g., older than a child of a particularage), above a particular maximum age (e.g., younger than a seniorcitizen), or is not associated with a learning disability.

Once activated, the therapy change user interface generated by the userinterface system 616 may provide one or more therapy change controlelements that enable the user to modify the one or more settings of theAMP 600. In some examples, the therapy control element may include anytype of user interface screen on the touchscreen, or other type of userinterface in the non-touchscreen context, that enables or permits a userto change a configuration of the AMP 600. This change in configurationof the AMP 600 may relate to a change in the therapy provided or in thedetection of a triggering event that causes therapy (e.g., medicamentdelivery) to be provided to a subject. For example, the change inconfiguration may include a selection between one or more hormones thatregulate blood sugar level (e.g., insulin or glucagon) of a user, anamount of the one or more hormones that regulate blood sugar level ofthe user, a rate of delivery of the one or more hormones, a thresholdfor determining when to deliver the one or more hormones, a change in anestimated blood absorption rate of the one or more hormones, and thelike. In some examples, the therapy control element may include any typeof user interface screen on the touchscreen, or other type of userinterface in the non-touchscreen context, that enables or permits a userto change one or more control parameters of the AMP 600 that control thetherapy delivery. In some cases, a simple interaction may include aninteraction that is capable of being performed by a person below aparticular age (e.g., a child), above a particular age (e.g., a seniorcitizen), or associated with a particular level of maturity orintelligence (e.g., a child or an individual with a learningdisability). In contrast, a complex interaction may include aninteraction that can be performed by an average adult or person that isabove a particular minimum age (e.g., older than a child of a particularage), above a particular maximum age (e.g., younger than a seniorcitizen), or is not associated with a learning disability.

In some cases, a change to the setting (e.g., control parameters orconfiguration of the AMP) of the AMP 600 is automatically and/orinstantly recognized or implemented by the AMP 600, and/or transmittedto the AMP 600. In some cases, a confirmation of the change may berequired before the setting change is implemented by or transmitted tothe AMP 600.

A confirmation of the change may be received in response to a seconduser interaction with a user interface (e.g., touchscreen display). Whenthe second user interaction is detected, the user interface system 616sends an input signal to the controller 602. If it is determined thatthe second user interaction satisfies a set of predefined conditions,the controller 602 implements the change to the configuration of the AMP600.

The first and/or second user interactions may include the selection ofan icon, a series of taps or inputs, one or more gestures (e.g., alinear swipe, an arcuate swipe, a circular swipe, or other simple orcomplex movement across the touchscreen), performing a pattern orsequence on the touchscreen (e.g., drawing an image), a multi-touch ormulti-input interaction, a combination of the foregoing, or any othertype of interaction with a touchscreen, or portion thereof. The seriesof inputs may be any combination of touch movements, touch points,numerical characters, alphabetical characters, and other symbols.Gesture interactions can be guided by visual indicia displayed orprinted on the AMP 600. In some embodiments, the visual indication caninclude animations that suggest or guide user interactions with atouchscreen. For example, the first user interaction can include anarcuate swipe around at least a portion of a generally circular icon orlogo. In some examples, the first and/or second user interactions mayinclude a predetermined sequence of numerical and/or alphabeticalinputs. In some examples, a series of multiple inputs, the range ofparameters for an input may be dependent on other inputs in the series.For example, required start position of a touch movement may bedependent on the position of the previous touch movement. The time thatthe series of inputs are entered may also be a part of the range ofparameters. For example, a series of inputs may need to be entered in noless than 3 seconds or more than 3 seconds, and no more than 15 secondsor less than 15 seconds.

Further, one or more of the interactions may include interacting with asensor, such as an optical sensor (e.g., visible light or IR sensor),biometric sensor (e.g., a fingerprint or retinal scanner), a proximitysensor, a gyroscope, or a combination of accelerometer and gyroscope,and the like. Also, in some cases, the second user interaction may bereceived through a wireless signal such as RFID or Bluetooth. In someembodiments, the second user interaction may include receiving aselection of a user interface element (e.g., a checkbox). Further, thesecond user interaction may correspond to a medicament type, such asinsulin or glucagon. In some cases, the second interaction maycorrespond to receiving a particular sequence of numerical inputs inorder to confirm the therapy change selection.

The type of user interaction that unlocks the touchscreen, providesaccess to a configuration screen, and/or confirms a change to theconfiguration of the AMP 600 may be the same or may differ.

In some examples, the system may have a time-out feature associated witha particular length time period. This particular length time period maybe of any length. For example, the time period until a time-out occursmay be 30 seconds, a minute, 5 minutes, etc. Further, the length of thetime period associated with a time out may be programmable. In some suchcases, if no interaction occurs during the particular length timeperiod, a time-out occurs. When a time-out occurs, a process formodifying an AMP 600 configuration may be cancelled. If the user electsto reattempt to modify the AMP 600 configuration after occurrence of atime-out, the process may be restarted. In some cases, the userinterface will turn off upon occurrence of a time-out, and as statedabove, the therapy change request process may be required to startagain. In one implementation of the time-out, if no interaction occursfor more than 30 seconds after the system is waked/unlocked before thesecond user interaction is received by the user interface, the userinterface will be deactivated.

In some implementations, once a change or modification to the therapysetting (e.g., a change in control parameters or configuration of theAMP 600) is confirmed, implemented, or transmitted, the AMP 600 maybegin operating based on the modified setting selected and/or providedby the user.

In some cases, operating with the modified setting may includetriggering therapy delivery based on the new setting or providingtherapy based on the new setting. For example, the AMP 600 may generatea dose control signal based at least in part on the modifiedconfiguration or control parameter or may detect a trigger based atleast in part on the modified configuration or control parameter thatleads to the provisioning of therapy.

In some cases, AMP 600, or a control device that enables a user tomodify a configuration of the AMP 600, may have a timeout feature. Thetimeout feature may cause the AMP 600 or the control device to enter asleep or locked state after a period of inactivity by the user. In somecases, the timeout feature may cause the AMP 600 or the control deviceto enter a sleep or locked state after a particular period regardless ofwhether the user is interacting with the ambulatory medicament device orcontrol device. In some cases, the timeout feature may cause the userinterface (e.g., a touchscreen display) to become inactive or enter alock state. Thus, a user may have a limited period to modify theconfiguration of the AMP 600.

In some examples, the therapy change made by a user may trigger thedelivery of a medicament according to the therapy change received andconfirmed by a user. This therapy change delivery may occur after a settime period from receiving the confirmation.

In some embodiments, the AMP 600 may allow the user to provide a therapychange and then cancel the therapy change. The user may provide thetherapy change by modifying one or more control parameters of the AMP600. The user may unlock a touchscreen display using a wake action andget access to a therapy change user interface (e.g., using a firstgesture), where one or more therapy change control elements may bedisplayed. Next, an indication of a modification to a therapy controlelement may be received by the user interface followed by a confirmationof the modification made (e.g., a second gesture). In response toreceiving an indication and confirmation of a modification to a therapycontrol element, the corresponding control parameter may be changed froma first setting to a second setting. In some examples, once the changeis implemented, the user may decide to cancel it or revert to a priorsetting. For example, the user may determine that the change iserroneous or does not provide the anticipated level of care. In somesuch cases, the user may provide a third gesture on the touch screen. Inresponse to receiving the third gesture from the user interface, thetherapy change procedure may restore the modified control parameter tothe first setting.

In some examples, the third gesture may be a restore gesture. In somecases, the restore gesture may be a swipe gesture. In some examples theswipe gesture may be performed near or in a region of the therapy changeuser interface that is occupied by the therapy control element (or aparticular portion thereof). An example of a restore swipe gesture maybe a gesture performed from a starting swipe position to an ending swipeposition located closer to a left edge of the touchscreen than thestarting swipe position. For instance, a user may position a finger at apoint on the touchscreen and drag the finger across at least a portionof the touchscreen towards a left edge (e.g., reminiscent of a backarrow). It should be understood that other gestures are possible toindicate a restore gesture. In some cases, a user can define the gestureto be used as a restore gesture. In some embodiments, the restoregesture is received on a different user interface screen than a therapychange user interface wherein one or more therapy control element areprovided. In various examples, the restore gesture is performed in theopposite direction from a therapy change confirmation gesture thatconfirms the modification to the therapy control element.

In some examples, in order to cancel a therapy change request, therestore gesture has to be provided within a set time period after theconfirmation gesture is received by the user interface. In some suchexamples, during the set time period one or more dose control signalsmay be provided to the medicament delivery interface resulting in one ormore therapy change deliveries. In some cases, the restore gesture canbe received at any time after the confirmation gesture or therapychange. In some cases, the restore gesture restores the controlparameter modified during a therapy change to an immediately precedingvalue. In some cases, the restore gesture restores the control parameterto a value designated as a restore value (e.g., a default value or otherdesignated restore value) or to a most recent value that maintained thesubject's blood glucose level with a target setpoint range. Thedesignated restore value may be specific to a subject or AMP 600 or maybe determined based on clinical data for a set of subjects. The set ofsubjects may be subjects that share certain characteristics with thesubject using the AMP 600. For example, the set of subjects may be ofthe same gender, similar age range, similar severity of diabetes, etc.

In some cases, the system may allow the user to modify a therapy changebefore confirmation. In these cases, the user may modify a therapycontrol element for a second time to change the corresponding controlparameter from a second setting to a third setting.

In some examples, the third setting may be the same as the firstsetting. In some cases, the first setting or the third setting may be adefault setting. In some cases, the first setting or the third settingmay be a restore setting.

In some examples, the user may be able to cancel a therapy changedelivery after confirming the therapy change and before a therapydelivery based on new settings. In some such examples, an alert maynotify the user that a therapy delivery based on new settings will occurshortly.

In some examples, the user may be able to cancel a therapy changedelivery triggered based on therapy change made by the user. In theseexamples, the user may get access to the user interface using a wakeaction and provide a gesture to cancel the ongoing therapy deliverybased on a therapy change delivery.

Therapy Data and Therapy Report

In some examples, AMP 600 may establish a communication with anelectronic device 702 to transfer therapy data to the electronic device702.

In some examples, the therapy data comprises dose or dosage datacorresponding to one or more doses of medicament provided by the AMP 600to the subject. Further, the therapy data may comprise subject datacorresponding to a medical or physiological state of the subject asdetermined by the AMP 600 (e.g., using the sensor 618).

In some examples, the data provided to AMP 600 may include any type ofdata that may be measured or obtained by the AMP 600 and may include arecord of therapy provided by the AMP 600. For example, the data mayinclude a time that therapy was provided, an amount of medicamentprovided as part of the therapy, a measure of one or more vital signs ofthe subject, a measure of blood glucose levels (e.g., measured bloodglucose level) at different times for the subject, a location of thesubject, and the like.

In some cases, the electronic device 702 may analyze the therapy datareceived from the AMP 600 and generate a therapy report. The therapyreport may include data relating to the subject's disease, treatment bythe AMP 600, anonymized comparisons with other subjects, statisticaldata relating to the subject's treatment, statistical data relating toother subjects' disease or disease management, and the like. Forexample, the therapy report may determine whether the subject ismaintaining blood glucose levels on average or whether control parametersettings for the AMP 600 are similar to an average subject with similarphysiological characteristics as the subject associated with the AMP600.

In some examples, the data, therapy data, and/or the therapy report maybe stored in a memory of the electronic device 702 and/or at a storageof the networked-computing environment.

In some examples, the therapy report or therapy data that is receivedand/or generated by a first electronic device may be transferred to asecond electronic device via a wired or wireless digital dataconnection. For examples, therapy data or therapy report may betransferred from a cloud server 708 to a mobile phone 706 or a personalcomputer 704.

In some cases, the first electronic device may be configured to at leastreceive a request from the second electronic device to access thetherapy report, therapy data or other data received by or stored in thefirst electronic device. In some cases, the second electronic device maybe a computing system of a medical practitioner (e.g., such as a doctor,nurse, physician's assistant, etc.), a guardian of the subject (e.g.,subject's parents), an authorized user (e.g., a user authorized by thesubject such as spouse, relative, friend, and the like), a healthcareprovider, or a device of the subject (e.g., mobile phone, personalcomputer, tablet and the like).

In some examples, the request to access the therapy data, therapyreport, or other data may include an account identifier associated witha user that generated the request. In some examples, the accountidentifier may comprise a unique identifier associated with the subject.Alternatively, or in addition, the account identifier comprises a uniqueidentifier associated with a user that is authorized to access thetherapy report. The user may or may not be the subject. In some aspectsof the present disclosure, the method may further include associatingthe therapy data with the account identifier at a storage of thenetworked-computing environment. Further, the first electronic devicemay be configured to determine whether an account associated with theaccount identifier is permitted to view the therapy report. In someexamples, account permissions may be granted and/or modified by thesubject. For example, the subject can access an account at a networkedcomputing environment, for example, a cloud network provided by a cloudservice provider associated with the subject, and provide one or moreidentifiers associated with one or more other users to give thempermission to access the subject's therapy data or report stored on acloud server 708.

Responsive to determining that the account is permitted to view thetherapy report, the first electronic device may transmit the therapyreport to the second electronic device over an encrypted communicationchannel (e.g., created by using asymmetric key pairs to encrypt the datatransmitted). Alternatively, or in addition, a shared secret may bedetermined for the first and the second electronic device. The sharedsecret may be used to encrypt the therapy report.

An association between a subject, a clinic, and/or an ambulatory medicaldevice may be performed by association of a device serial number of theAMP 600 with the subject and/or clinic. Further, a user (e.g., asubject, clinician, or parent) can access therapeutic recommendationsthrough the cloud in case either the ambulatory medical device (e.g., aninsulin pump) or the CGM sensor fails to function.

In some cases, the method may include receiving an identity oridentification information of one or more users that are authorized toaccess therapy data stored at the networked-computing environment. Forexample, a user or subject may authorize a clinician or other healthcareprovider, a parent or guardian, or other users that the subject desiresto have access to the therapy data. The identity information of the oneor more users may include any type of information that may identify theuser or enable the user to be authenticated. For example, the identityinformation may include a name, unique identifier (e.g., social securitynumber), an email, an address, a phone number, account information forthe user at the networked-computing environment, or any otheridentifying information.

Managing Control Parameters in an Ambulatory Medical Device

It is often desirable to modify therapy settings of an AMP to improve ahealth condition of a subject who receives therapy from the AMP. Atherapy setting may include values of one or more control parametersthat control therapy delivery to a subject. In some AMPs, the controlparameters may be changed via therapy change controls provided in a userinterface of the AMP. For example, when an ambulatory medicament pump(AMP) controls the blood glucose level in a subject, modifying therapysettings may comprise changing a glucose level set point, a basal dose,a meal dose, a correction does, or type of insulin delivered to thesubject. In some cases, a healthcare provider may decide to modify thetherapy settings based on the results of medical examinations, bloodtests, history of patient's response to therapy provided by the AMP, acombination of these factors or other reasons. In some other cases, thesubject or an authorized user of the AMP may desire to modify thetherapy settings during a test period in order to evaluate the outcomesof different therapy settings and/or to identify a therapy setting thatresults in an improvement of the subject's health condition as comparedto other settings used during the test period or previously used.

Given the risks associated with selecting incorrect therapy settings byan inexperienced or untrained user, in some embodiments, access to theone or more therapy change controls of an AMP may be limited orrestricted. For example, access to certain therapy change controls maybe only granted to a user or a subject for a limited time and/or basedon an evaluation process that takes into account the user's or thesubject's knowledge, experience, level of training, age, mental healthor other conditions/factors that may affect the ability of the user orthe subject to modify the therapy settings without putting the subject'shealth at risk or while limiting the risk to the subject. In someexamples, access may be only provided to certain therapy change controlsrequired for changing control parameters that are identified based onthe health condition of the subject (e.g., determined through medicaltests and/or based on therapy data collected during one or more therapyperiods). In some examples, the range of values that can be selected forone or more control parameters may be limited to avoid potential harmfuleffects that may result from setting the value of those parametersoutside of the identified “safe range” for a particular subject. In somecases, access to one or more therapy change controls may be provided toa user who may use the AMP for medical research. In yet other cases,access to one or more therapy change controls may be granted to anapplication developer who is developing, modifying, or debugging acontrol software used by AMP's control system. In some embodiments,access to a plurality of therapy change controls may be granted for alimited time.

To provide user access to one or more therapy change controls of an AMPwithout putting the health of a subject at risk, in some embodiments,access to therapy change controls may be managed using a plurality ofsafe access levels for the AMP. Each of the safe access levels maycorrespond to one or more control parameters that can be modified by auser or a subject who is qualified to modify the one or more controlparameters and/or is associated with the corresponding safe accesslevel. In some examples, access to the selected control parameters maybe allowed by enabling access to the corresponding therapy changecontrols in the AMP (e.g., activating or displaying one or more therapychange control elements on a touchscreen user interface).

In some embodiments, the user may be qualified for a safe access levelonly during a validity period of the safe access level. After thevalidity period, the therapy change controls associated with the safeaccess level may become inactive or unavailable until the user or thesubject is revaluated for the same or another safe access level duringanother validity period. In some embodiments, the AMP may provide theuser with the option of extending the validity period of the safe accesslevel. In some embodiments, the validity period may be open ended or mayexpire when the subject associated with the ambulatory medicament pumpchanges. In some other embodiments, the validity period can be one hour,one week, one month or other time periods.

In some cases, safe access levels may be categorized based on thecapacity of a user for modifying control parameters without causing harmor increasing the risk of harmful effects to the subject. For example,safe access levels may be defined based on age, training, experience,and the like. In other cases, safe access levels may be defined orcategorized based on a therapy history of the subject. For example, safeaccess levels may be defined based on certain events or behaviorsidentified in the therapy data collected in the previous therapy periodswhen the subject was receiving therapy from the AMP. In yet other cases,one or more safe access levels may be defined based on a desire tomodify therapy settings when the AMP does not provide therapy to humansubjects and/or is used to perform investigative research. For example,a safe access level may be dedicated to users who use the AMP formedical research and another safe access level may be dedicated to userswho develop applications for the AMP.

In one non-limiting example, four safe access levels (G0 to G3) may bedefined for four groups of users where: G0 may be the safe access levelfor children or certain adults with diminished mental capacity. Thetherapy change controls available to this group may permit changing thevalue of one or more control parameters to preset values or back tovalues previously used. However, other changes to the therapy changecontrols or changes to other therapy change controls may be restricted.G1 may be a safe access level that is associated with adults who havelittle experience and/or have only received basic training for using theAMP. The therapy change controls available to this group may enablemodification of few control parameters within a safe range. G2 may be ssafe access level that is associated with experienced adults and/or havereceived advanced training. The therapy change controls available tothis group may enable modification of several control parameters withina range that may include parameter values that may not be safe to use orthat are only safe to use in limited circumstances. G3 may be a safeaccess level that can be associated with medical researchers orapplication developers. The therapy change controls available to thisgroup may provide access to a larger number of therapy change controlsand allow selecting a wide range of values for each of the controlparameters. In some cases, the settings may include values that areunsafe for a typical subject. It should be understood that theaforementioned safe access levels is just one example set of safe accesslevels. Greater or fewer numbers of safe access levels may exist.Further, the safe access levels may be associated with different typesof users and/or may provide different levels of control over the AMP.

For example, the AMP may be associated with three safe access levels (T1to T3). The three access levels may comprise access levels defined basedon the level of training received by a user or the subject who receivestherapy from the AMP. T1 may be the safe access level associated withusers who have received a basic level of training for the AMP. T2 may bethe safe access level associated with users who have received anintermediate level of training for the AMP. T3 may be the safe accesslevel associated with users who have received advanced training for theAMP. The determination of basic, intermediate, or advanced training maybe made or specified by a healthcare provider and/or manufacturer of theAMP. In some examples, the therapy change controls available to each ofthe groups may only provide access to the control parameters that areassociated with the requisite training. In some cases, the training maybe provided by a healthcare provider, a physician, or a trainer whoworks under the supervision of the physician or the healthcare provider.In some cases, training data may be used by the healthcare provider oran electronic device to determine the training level for a user or asubject. Training data may comprise, a training certificate (e.g., adigital training certificate), a list of training courses taken orpassed, AMP features and control parameters included in the training,and the like.

In some embodiments, new safe access levels may be defined by amanufacturer, healthcare provider, or other users. The new safe accesslevel may be defined based on one or more control parameters of the AMPthat are accessible to a user. Further, a new safe access level can bedefined by combining existing safe access levels and/or by specifyingdifferent criteria to determine whether a user may access a controlparameter. For example, three safe access levels may be defined to limitthe therapy change controls accessible by different categories of users,such as children, adults who may have different training levels, and/orusers who may have limited or reduced mental capacity. In one example, asafe access level may be formed by combining the aforementioned safeaccess levels G0 and T1, G0 and T2, and G0 and T3. These three new safeaccess levels may be used to provide access to selected therapy changecontrols to child users that have received basic, intermediate, oradvanced training, respectively.

In some cases, a safe access level may permit selecting specific valuesof one or more control parameters. In some examples, a safe access levelmay enable modifying the corresponding control parameters during a setsafe access period associated with the safe access level. In someexamples, the safe access period for one or more control parametersassociated with a safe access level can be different from the safeaccess period for other control parameters associated with the safeaccess level.

In some embodiments, a safe access level may be stored in a memory ofthe AMP as a safe access profile that can include a list of therapychange controls associated with the safe access level. In some examples,a safe access profile may be used by the controller of the AMP (e.g.,controller 602 of AMP 600) to enable access to the corresponding therapychange controls upon receiving an indication that the subject receivingtherapy from the AMP or an authorized user, is qualified for the safeaccess level associated with the safe access profile.

In some embodiments, the AMP can be an ambulatory medicament pump (AMP)that controls the blood glucose level in a subject by infusing doses ofinsulin (or insulin and a counter regulatory hormone such as glucagon)into the subject. In some such embodiments, the AMP may continuouslymeasure the blood glucose level of the subject using a sensor and adjustthe infusion time and volume of each medicament dose based at least inpart on the measured glucose level. For some such AMPs, somenon-limiting example control parameters may include, but are not limitedto: 1) dose control parameters for autonomous delivery, such as: glucoselevel set point, bolus size, basal rate, duration of each therapy, 2)correction factors, 3) carbohydrate ratios, 4) control algorithmparameters such as: predicted CGM user interface, automated correctionfactors, Kalman filter parameters, control parameters that account foraccumulation of insulin in the subject, learning factors, 5) medicamenttype such as: U200, U100, ultra-rapid insulin, fast-acting insulin, 6)correction doses, and 7) manual meal doses.

In some cases, a safe access level for an AMP may include access to oneor more of the above-mentioned control parameters and/or may includespecific safe ranges within which these parameters can be changed by theuser or the subject.

In some embodiments, access to one or more therapy change controls of anAMP may be provided to the user or the subject, to facilitateidentifying the values of one or more control parameters that may resultin an improvement of the glycemic control of the subject. In some suchembodiments access to the corresponding therapy change controls mayenable the user or the subject to actively participate in the adjustmentprocess (e.g., by systematically modifying the control parameters andcarefully monitoring the therapy effects). In other embodiments, accessto the corresponding therapy change controls may enable the subject(e.g., a child subject or an inexperienced subject) to revert the newlyselected values for one or more control parameters to preset values orpreviously used values, when experiencing adverse health effects duringa test period (e.g., a period used to test the therapy effects of newlyselected values).

As mentioned above, in some cases the access to therapy change controlsmay be provided based on a health condition of the subject. As such,safe access levels for an AMP that controls the glucose level in asubject, may be categorized based on previous glycemic control of thesubject by the AMP. For example, in some non-limiting cases, there maybe three categories of safe access levels: a first category, H1, may bethe safe access level for subjects with high risk of hypoglycemia. Thisaccess level may provide access to therapy change controls that can beused to adjust one or more control parameters that control the volume orrate of a counter regulatory hormone (e.g., glucagon), needed to avoidhypoglycemia or to increase the blood sugar level during an episode ofhypoglycemia. A second category, H2, may be the safe access level forsubjects with moderate risk of hyperglycemia. This access level mayprovide access to the same therapy change controls as the safe accesslevel H1, however the maximum infusion rate or the maximum volume of themedicament infused during each therapy that can be selected by a userwho is qualified for this safe access level, may be limited in order toreduce the probability of hypoglycemia. A third category, H3, may be thesafe access level for subjects with high risk of hyperglycemia. Thisaccess level may provide access to therapy change controls that can beused to adjust control parameters that control the frequency of therapyand/or the amount of medicament delivered during each therapy (e.g., atherapy control parameter associated with accumulation of insulin in thesubject), so that the user or the subject can increase the amount ofinfused medicament during an episode of hyperglycemia. In someembodiments, safe access levels may be categorized based on otheraspects of the glycemic control of a subject by the AMP. It should beunderstood that the above is just one non-limiting example of safeaccess levels. It is possible for there to exist more or fewer safeaccess levels. Further each safe access level may be associated withdifferent risk, therapy change controls, user/subject characteristics,and the like.

In some embodiments, a safe access level may be used to allow a subjector a user eligible for the safe access level to change the value of oneor more control parameters beyond a normal range that can be selected byusers who are not qualified for the access level. In some examples, asafe access level may be used to allow a user or the subject to enableor disable one or more features of the AMP.

As mentioned above, in some embodiments, a safe access level may belimited to a validity period (e.g., a limited or an open-ended validityperiod, or a validity period that expires when the subject associatedwith the ambulatory medicament pump changes) after which the user or thesubject loses access to the corresponding therapy change controls. Forexample, the validity period for safe access level H1 described abovemay be limited to a period during which the subject is expected to havehigh level of physical activity (e.g., exercise, hiking, swimming andthe like). In some cases, a particular user may be granted access totherapy change controls associated with a safe access level for a longeror shorter period than another user.

Method of Determining Eligibility for a Safe Access Level

In some cases, an electronic evaluation device, a healthcare provider(e.g., a physician) or a trainer who provides training for an AMP (e.g.,a certified trainer who works in a physician or a healthcare provider'soffice and or in hospital) may determine one or more safe access levelsfor which a subject receiving therapy from the AMP or a user of the AMP,is eligible for. In some cases, the user may be authorized by ahealthcare provider or the subject to make changes to the settings of anAMP that provides therapy to the subject. In some other cases, theelectronic evaluation device, a healthcare provider or a trainer maydetermine the eligibility of the user or the subject for a selected safeaccess level. The selected safe access level may be selected by theuser, the subject, the healthcare provider, or the trainer. In someexamples, the electronic evaluation device, the healthcare provider orthe trainer may also determine a validity period for the safe accesslevel granted to the user. In some examples, the validity period may belonger or shorter than the safe access period associated with the safeaccess level. In some such examples, the AMP may use the validity periodprovide access to the corresponding therapy change controls. In someembodiments, the electronic evaluation device may determine whether theperiod during which access to one or more therapy change controls isprovided is limited by the validity period (e.g., determined by theelectronic evaluation device) or the safe access level period associatedwith the safe access level.

The electronic evaluation device can be: a cloud server, the AMP thatprovides therapy to the subject, a personal electronic device of theuser or the subject (e.g., a desktop or laptop computer, a mobilephone), a personal electronic device of a healthcare provider or atrainer (e.g., a desktop or laptop computer, a mobile phone), anelectronic device used by the healthcare provider or the trainer (e.g.,a computer in a physician's or a healthcare provider's office, a computein medical center or a clinic, and the like).

In some cases, a physician or other healthcare provider may determine asafe access level for a user and/or a validity period for the safeaccess level, based at least in part on evaluation data available or theuser.

The evaluation data may comprise information about the user or thesubject including but not limited to: age, mental condition, healthcondition, level of training, medical history, therapy data, therapyreport, past history of managing the AMP, previous safe access levelsgranted, results of one or more medical tests (e.g., blood analysis,urine analysis, and the like), training data. The physician may haveaccess to the evaluation data stored in a non-transitory memory (e.g.,memory in a cloud server or an electronic device) or may receive theevaluation data from the AMP or another electronic device (e.g., througha wired or wireless digital data connection). In some examples, thetherapy data may have been collected by an AMP that controls thesubject's blood glucose concentration. In such examples, therapy datamay include measured values of blood glucose concentration in thesubject, doses of insulin (or glucagon) infused into the subject,infusion times and the like.

In some examples, a physician or healthcare provider may use theevaluation data to determine one or more safe access levels for whichthe subject or the user are qualified and select a safe access level anda validity period that allow modifying the therapy change controlparameters needed to improve a health condition of the subject viatherapy.

In some cases, the physician or healthcare provider may provide accessto a combination of therapy change controls that are not associated witha single available safe access level, that are associated with multiplesafe access levels, or that are split across multiple safe accesslevels. For instance, in some cases, a first therapy change control maybe associated with a first safe access level and a second therapy changecontrol may be associated with a second safe access level. In such casesembodiments, the physician or healthcare provider may create acustomized safe access level to enable a subject or a user access to thecombination of therapy change controls. Once created, a customized safeaccess level may be saved and may be available for future use.

In some cases, a trainer of a user of an AMP may determine a safe accesslevel for the user or determine the eligibility of the user for aselected safe access level (e.g., a safe access level selected by aphysician or a healthcare provider or a healthcare provider) based atleast in part on the level of training provided to the subject or theuser. In some such cases, the trainer may use the evaluation dataavailable for the subject or the user, to determine a safe access levelfor the user. In some cases, the trainer may also determine a validityperiod for the safe access level determined by the trainer or theselected safe access level.

In some embodiments, the electronic evaluation device may determine asafe access level for a user based on the evaluation data received froman electronic device. In some other embodiments, the electronicevaluation device may determine the eligibility of the subject or theuser for a selected safe access level based on the evaluation datareceived from an electronic device. In some cases, the electronicevaluating device may determine a validity period for the safe accesslevel (determined by the electronic evaluation device) or the selectedsafe access level.

The evaluation data may comprise information about the subject includingbut not limited to: age, mental condition, health condition, level oftraining, medical history, therapy data, therapy report, past history ofmanaging the AMP, previous safe access levels granted, results of one ormore medical tests (e.g., blood analysis, urine analysis, and the like),training data. In some cases, the evaluation data may also include oneor more prescriptions of the subject (e.g., provided by a healthcareprovider), a recommendation from a healthcare provider and the like.

In some examples, the evaluation data may be stored in a memory of theelectronic evaluation device. In some other examples, the electronicevaluation device may receive the evaluation data from an electronicdevice via a wired or wireless data link. The electronic device maycomprise: the AMP, a cloud server, a personal electronic device of ahealth care provider or a trainer, an electronic device used by a healthcare provider or a trainer or a personal electronic device of thesubject or the user.

In some embodiments, the electronic evaluation device may determine asafe access level for a user in response to receiving a trigger. Thetrigger may be an access request received from an electronic device(e.g., a cloud server, a personal electronic device of the user, ahealthcare provider or a trainer, or an electronic device used by thehealthcare provider or the trainer), via a wired or wireless dataconnection. Upon receiving the access request, the electronic evaluationdevice may use the evaluation data available for the user to determine asafe access level for which the user may be eligible for. The validityperiod for the safe level access may be included in the access requestor may be determined by the electronic evaluation device.

In some examples, the electronic evaluation device 802 may determine theeligibility of the user for a selected safe access level in response toreceiving a trigger. In some cases, the trigger may be an eligibilityrequest received from an electronic device (e.g., a cloud server, apersonal electronic device of the user, a healthcare provider or atrainer, or an electronic device used by the healthcare provider or thetrainer), via a wired or wireless data connection. In some cases, asubject who uses an AMP to control his or her blood glucose level, maysend an eligibility request for a safe access level to an electronicevaluation device, in order to gain access to one or more therapy changecontrols associated with the safe access level. For example, the subjectmay need access to therapy change controls associated with changing thetype of insulin received. The subject may select a safe access level,that includes therapy change controls for changing the insulin type andsend an eligibility evaluation request for a safe access level to ethelectronic evaluation device. After receiving the eligibility request,the electronic evaluation device may search for a prescription for a newtype of insulin. If the prescription is found, the electronic evaluationdevice may search for other types of evaluation data (e.g., traininglevel, age, prior safe access level granted, physician recommendationand the like), to further evaluate the eligibility of the subject forthe safe access level.

In some implementations, the electronic evaluation device 802 maydetermine the eligibility of the user (or the subject) for a selected orrequested safe access level using an interactive evaluation process. Theinteractive evaluation process may include an interaction with the useror the subject via one or more user interfaces of the electronicevaluation device 802 (e.g., a touchscreen display, a keyboard, amonitor, a mouse, an interactive software interface, an interactive webpage and the like). For example, the interactive evaluation process mayinclude displaying a set of queries, corresponding to one or more usecases of the AMP 600, to the user and the receiving a set of responsesto the set of queries. Subsequently, the electronic evaluation device802 may evaluate the set of responses to obtain an evaluation score anduse the evaluation score to determine selected safe access level for theuser.

Providing Access Based on a Safe Access Level

As described above, the access to one or more therapy change controls ofan AMP may be enabled only if a safe access level that is associatedwith the one or more therapy change controls is granted to a user of theAMP or a subject receiving therapy are from the AMP. In someembodiments, once the safe access level is granted to the user or thesubject (e.g., based on an evaluation process performed by a trainer,physician or an electronic evaluation device), the AMP may enable accessto one or more therapy change controls upon receiving a passcode (e.g.,a time-based passcode) via a user interface (e.g., a passcode entryinterface), or receiving an access signal (e.g., from an electronicaccess device). The access signal can be an analog or a digital signal.In some cases, the information regarding the safe access level grantedto the subject may be encoded in the access signal. For example, thegranted safe access level signal, one or more therapy change controlsassociated with the grated safe access level, and/or a validity periodof the granted safe access level may be encoded in eth access signal.

In some embodiments, the access to one or more therapy change controlsof an AMP may be passcode protected. In some such embodiments, when asafe access level and a validity period are determined for a subject whoreceives therapy from an AMP (or an authorized user of the AMP), anelectronic access device or the electronic evaluation device maygenerate and send a passcode (e.g., a time-based passcode), associatedwith the safe access level and the validity period, to the AMP. In someexamples, the time-based passcode and the validity period are stored ina memory of the AMP and may be used to provide access to the therapychange controls corresponding the safe access level during the validityperiod. In some such examples, the time-based passcode may expire afterthe validity period.

In some other embodiments, when a safe access level is determined for asubject who receives therapy from an AMP (or an authorized user of theAMP), an electronic configuration device may generate a passcode (e.g.,a time-based passcode), associated with the safe access level based atleast in part on a public identifier received from the AMP. In some suchembodiments, the passcode may be provided directly to the user or thesubject by an operator or administrator of the electronic configurationdevice over a communication link (e.g., a wired or wireless phone line).In some examples, the operator or the administrator may provide thepasscode via a voice call, voice message, or text message. In some otherexamples, the electronic configuration device may send the passcode viaa text message to the user's phone (e.g., a smart phone).

In some cases, where a healthcare provider or a trainer determines theeligibility of the subject or the user for a safe access level, they mayuse an electronic access device to generate the time-based passcode andsend it to the AMP. An electronic access device can be a cloud server, apersonal electronic device of a healthcare provider or a trainer (e.g.,a desktop, laptop computer, or a mobile phone), or an electronic deviceused by the healthcare provider or the trainer (e.g., a computer in aphysician's or healthcare provider's office, a compute in medical centeror a clinic, and the like). For example, a physician or a healthcareprovider may select the safe access level and send the correspondingtime-based passcode to the AMP using a user interface of the electronicaccess device.

In some embodiments the electronic evaluation device that has determinedthe safe access level and the validity period for the user or hasdetermined the eligibility of the user for a selected safe access level,may generate the corresponding time-based passcode and automaticallytransmit it to the AMP using a wired or wireless data connection.

When a time-based passcode associated with a safe access level isreceived and stored in a memory of the AMP, the controller of the AMPmay provide a passcode entry element on a user interface of the AMPwhere the user or the subject can provide a passcode by interacting withthe user interface. In some examples, the AMP may also receive (e.g.,from the electronic evaluation or access device) a validity period forthe safe access level. In such examples, the passcode may expire afterthe validity period.

In some embodiments, the access to one or more therapy change controlsof an AMP may be enabled using an access signal. In some suchembodiments, when the a safe access level and a validity period aredetermined for a subject who receives therapy from an AMP (or anauthorized user of the AMP), an electronic access device or theelectronic evaluation device may generate and send an access signal,associated with the safe access level and the validity period, to theAMP. In these examples, upon receiving the access signal, the AMP mayprovide user access to one or more therapy change controls associatedwith the safe access level during the validity period.

In some embodiments, the therapy change controls associated with a safeaccess level may be stored in a memory of the AMP as a safe accessprofile. In some examples, the AMP may store a plurality of safe accessprofiles associated with a plurality of safe access levels (e.g., safeaccess-levels G0-G3 or T1-T3 described above). A safe access profile maycomprise a list of therapy change controls for changing controlparameters associated with the corresponding safe access level.Alternatively, or in addition, the safe access profile may include arange of values that may be selected for the control parameters. In someexamples, the safe access profile may comprise a safe access period forthe safe access level. In these examples, the access to thecorresponding therapy change controls may be denied after the safeaccess period. In some example, a validity period received with the safeaccess level, may reduce or extend the safe access period for a safeaccess level.

In some embodiments, instead of generating and sending a passcode, theelectronic access device or the electronic evaluation device may send anaccess signal to the AMP to enable access to the therapy change controlsassociated with a safe access level granted to a user of the AMP. Theaccess signal may be transmitted from the electronic access device orthe electronic evaluation device via a wireless data connection (e.g.,via a LAN, WAN, Bluetooth, or an NFC signal). In some examples, thewireless data connection may be a direct end-to-end connection. When theaccess signal is received by the AMP, the AMP may provide access to thetherapy change controls included in the safe access profile associatedwith the safe access level. In some examples, the access signal receivedby the AMP may enable access to the therapy change controls, associatedwith the granted safe access level during a validity period determinedby the electronic evaluation device, a healthcare provider or a trainer.

In some examples once a safe access level is determined, it may bestored in the electronic evaluation device, electronic access device,the AMP or other electronic devices (e.g., an electronic device of theuser, the subject, the healthcare provider, or the trainer). In someexamples, one or more determined safe access levels that have beenstored, may be used to provide access to the corresponding therapychange controls on a new AMP. In some examples, one or more determinedsafe access levels that have been stored, may be used to extend the safeaccess period or determining eligibility for the same and or anothersafe access level at a later time.

In some embodiments, an authorized user or a subject who has beengranted a safe access level can change one or more of the correspondingcontrol parameters to create a personalized therapy setting. Apersonalized therapy setting may be used for an unlimited time period orset indefinitely, expire after a set time period (as may be set, forexample, by a physician), expire at the end of the safe access period(e.g., when time-based password expires), or expire after use ormodification of a therapy change control (either once or a set number oftimes). In some cases, the user or the subject may change thepersonalized setting to a standard setting (e.g., shared setting) at anytime or before a set period. In some cases, the personalized therapysetting may be used until a trigger occurs or until a new therapysetting is received.

In some examples, if the AMP detects that an unsafe level of therapy isdelivered or may be delivered as a result of changes made based on asafe access level, the AMP may automatically change the value of thecorresponding control parameters to safe values or may reject aparticular change to a therapy change control. Safe values may bepreviously used values, values determined by the AMP based on past orpresent therapy data, or other values stored in a memory of the AMP. Forexample, if the blood glucose level of a subject who receives therapyfrom an AMP that provides insulin to the subject drops below a thresholdvalue as a result of reducing the glucose set point during a safe accessperiod, the controller of the AMP may automatically change the glucoseset point back to an earlier set value.

In some embodiments, the validity period of a safe access level grantedto a user or a subject receiving therapy from the AMP, may be extendedby the user or the subject. For example, the user or the subject maygenerate a request for extension of the validity period via a userinterface of the AMP. In some cases, the request for extension may betransmitted to an electronic evaluation device that determines whetherthe requested extension can be granted the user or the subject. Upondetermining that the extension can be granted, the electronic evaluationdevice may send an extension signal to the AMP. Upon receiving theextension signal AMP may extend the expiration of the correspondingtime-based passcode to a new ending time or enable access to thecorresponding therapy change controls until the new ending time. In someexamples, the ending time may be included in the request for extension.In some other examples, the ending time may be determined by theelectronic evaluation device. In some embodiments, the user may send therequest for extension to a healthcare provide or a trainer. In some suchembodiments, the request for extension may be transmitted from the AMPto an electronic device of the trainer or the healthcare provider,directly or via an intermediary electronic device. The healthcareprovider or the trainer, may approve the new ending time included in therequest for extension or determine another ending time. The healthcareprovider or the trainer, may use an electronic access device to extendthe validity period of a granted safe access level.

In some case, after changing the values of one or more controlparameters associated with a granted safe access level, a user or asubject may desire to restore previously used values of the one or morecontrol parameters. In some such cases, the AMP may provide the user orthe subject with the option of restoring previously used values of theone or more control parameters. For example, the AMP may provide a userinterface (e.g., a menu on a touchscreen interface) that includes one ormore restoring elements that may enable restoring the previously usedvalues of the one or more control parameters.

As mentioned above, the validity period of a safe access level grantedto a user (or the subject receiving therapy from the AMP 600), may beextended by the user or the subject. In some implementations, extendingthe validity period may require re-evaluating the eligibility of theuser for the safe access level that was previously granted to the userbased on an initial evaluation process described above. In some cases,unlike the initial evaluation process, the re-evaluation process may notinvolve the physician, the healthcare provider or the trainer. Forexample, the subject may send a validity period extension request to theelectronic evaluation device 802 (e.g., via a wired or wirelessconnection, or a user interface), and the electronic evaluation device802 may re-evaluate the eligibility of the user for the safe accesslevel based on a record of the user's use of the pump during thevalidity period. For example, the electronic evaluation device 802 maydetermine whether changes made by the user to the one or more therapycontrol parameters resulted in increased occurrences or risk ofhypoglycemia or hyperglycemia during the validity period. If theelectronic evaluation device 802 determines that user's use of the pumpduring the validity period did not result in increased occurrences orrisk of hypoglycemia or hyperglycemia during the validity period, it mayextend the validity period of the safe access level and allow the userto use the corresponding control settings of the AMP during an extendedvalidity period. In some cases, the electronic evaluation device 802 mayalso use the evaluation data 810, which may have been updated during thevalidity period, to re-evaluate the eligibility of the user for the safeaccess level. In some cases, the electronic re-evaluation device may usethe interactive evaluation process described above to re-evaluate user'seligibility for the safe access level for an extended validity period.In some cases, if the electronic evaluation device 802 determines thatuser's use of the pump during the validity period resulted in periods ofhypoglycemia or hyperglycemia during the validity period, it may denythe validity period extension request and notify the user (e.g., via auser interface of the AMP 600 or a user interface of the electronicevaluation device 802).

Additional Features

In some embodiments, the settings (e.g., therapy settings) of an AMP maybe changed remotely using an electronic control device. For example, anelectronic control device may transmit a command to the AMP via a wiredor wireless digital data link to change the values of one or morecontrol parameters of the AMP or change certain settings of the AMP. Theelectronic control device can be personal computer, a mobile phone acloud server or other computing devices configured to communicate withthe AMP. In some examples, the data connection between the electroniccontrol device and the AMP may be established using one of the methodsdescribed with respect to FIG. 7.

In some embodiments, when a user or a subject obtains a new AMP, aonetime passcode may be provided to the user or the subject that can beused to download the therapy settings and subject's data from a remoteelectronic device, in order to activate and update the new AMP. In somesuch embodiments, if the new device is activated and updated during thevalidity period of a safe access level (previously granted to the useror the subject), the AMP may allow the user or the subject to access thecorresponding therapy change controls using the previous passcodeassociated with the safe access level. In some examples, if the new AMPis activated and updated during the validity period of a safe accesslevel, the AMP may automatically enable access to the correspondingtherapy change controls without requesting a passcode.

Example Embodiments

FIG. 8A-FIG. 8C present three example embodiments for managing access toone or more therapy change controls of AMP 600 based on safe accesslevels.

In the embodiment shown in FIG. 8A, an electronic evaluation device 802may determine a safe access level for the user or the subject based onreceived evaluation data 810. The evaluation data may be received via awired or a wireless connection with: an electronic device of a traineror a healthcare provider, the AMP 600, or a cloud server 708. In someexamples, the evaluation data 810 may be stored in the electronicevaluation device 802. In some other examples, the evaluation data 810may be received at least partially via a user interface of theelectronic evaluation device 802. For example, a healthcare provider ora trainer may provide the evaluation data 810 via an interaction withthe user interface.

In some examples, the electronic evaluation device 802 may determine theeligibility of the user or the subject for a selected safe access level(e.g., a safe access level selected by the user, the subject, ahealthcare provider or a trainer) based on received evaluation data 810.In some examples, the selected safe access level may be included in theevaluation data 810. In some other examples the selected safe accesslevel may be received from the AMP 600, a personal electronic device ofthe user, a personal electronic device of the healthcare provider or thetrainer, or an electronic device used by a healthcare provider or atrainer. For example, a healthcare provider may determine that the userneeds or should have access to one or more therapy change controlsassociated with a safe access level and the healthcare provider mayselect that safe access level. Subsequently, the healthcare provider mayuse his/her mobile phone, personal computer or computer in a healthclinic, to send a request to the evaluation device 802 for determiningthe eligibility of the user for the selected safe access level.

Once a safe access level for which the user or the subject is eligible,or the eligibility of the user or the subject for a selected safe accesslevel is determined, the electronic evaluation device 802 may generateand send a passcode to the AMP 600 to enable access to the correspondingtherapy change controls upon receiving the same passcode from the user(e.g., via a user interface of the AMP 600). The passcode may be sent tothe AMP 600 via a wired or wireless data connection. In some examples,the passcode may be a time-based passcode that can be only used to getaccess to the corresponding therapy change controls within a validityperiod. In some examples, the validity period may be determined by theelectronic evaluation device 802. In some examples, the validity periodmay be included in the evaluation data 810. In some examples, thevalidity period may be included in the access request for a selectedsafe access level (e.g., sent by a physician or a healthcare provider ora trainer). In some examples, upon receiving the passcode the AMP 600may notify the user that a passcode is received (e.g., by displaying anindicator in a main screen displayed on a touchscreen display). If thepasscode is a time-based passcode, AMP 600 may also display the validityperiod of the safe access level on a display of the AMP (e.g., on atouchscreen display).

As illustrated in FIG. 8B, in some embodiments, the passcode (e.g., atime-based passcode) may be sent to the AMP 600 by an electronic accessdevice 806 that receives a safe access level from an electronicevaluation device 802 that has determined the safe access level forwhich the user or the subject is eligible for, or the eligibility of theuser or the subject for a selected safe access level 804. In someexamples, the safe access level 804 may be transmitted via a wired orwireless data connection to the electronic access device 806. In someexamples, the electronic evaluation device 802 may also send anindication of a validity period for the safe access level to theelectronic access device 806.

As illustrated in FIG. 8C, a healthcare provider 812 or a trainer 814may select a safe access level 808 and determine the eligibility of theuser or the subject for a selected safe access level 808. In some suchembodiments, the healthcare provider or the trainer may provide the safeaccess level 808 to an electronic access device 806, for example, via auser interface of the electronic access device 806. In some examples,the healthcare provider 812 or the trainer 814 may send the safe accesslevel 808 to the electronic access device 806 using his/her personalelectronic device via a wired or a wireless link. Upon receiving thesafe access level 808, the electronic access device 806 may send apasscode to the AMP 600. In some examples, the passcode may be atime-based passcode that can be only used to get access to thecorresponding therapy change controls within a validity period. In somesuch examples, the healthcare provider 812 or the trainer 814 may alsodetermine a validity period for the safe access level 808 and provide itto the electronic access device 806 along with the safe access level.

In some cases, instead of a passcode or a time-based passcode, theelectronic evaluation device 802 (in FIG. 8A) or the electronic accessdevice 806 (in FIG. 8B and FIG. 8C) may send an access signal to the AMP600. Upon receiving the access signal, the AMP 600 may provide access tothe therapy change controls associated with the determined or theselected safe access level. For example, when an access signal isreceived by the AMP 600, the AMP 600 may activate one or more inactivetherapy change control elements (associated with a safe access level) ina therapy change interface of the AMP 600. In some examples, uponreceiving the access signal, the AMP 600 may notify the user or thesubject that safe access level has been granted (e.g., by providing anindicator in a main screen displayed on a touchscreen display). If thesafe access level is provided during a validity period, the AMP 600 mayalso display the validity period of the granted safe access level on adisplay of the AMP 600.

In some cases, when the eligibility of the subject or the user for asafe access level is determined or a safe access level have beendetermined for the subject or the user, the electronic evaluation device802 (in FIG. 8A), electronic access device 806 (in FIG. 8B and FIG. 8C)or other remote electronic devices may send a signal or a message theAMP 600 indicating that a safe level access has been granted to the userof AMP 600 or to the subject receiving therapy from AMP 600. In somesuch cases, upon receiving the signal or the message, AMP 600 mayestablish a data connection via a digital data interface (e.g., adigital data interface of the communication system 622) with electronicevaluation device 802 or electronic access device 806, in order toreceive a passcode or an access signal.

FIG. 9 presents a flowchart of an example process for providing accessto the therapy change controls associated with a safe access level inaccordance with certain embodiments.

The process 900 may be performed by an ambulatory medicament pump (AMP),such as an AMP that provides insulin therapy to a subject, an AMD 100,or a glucose level control system. For example, the process 900 may beperformed by one or more elements of the AMP 600 (e.g., the controller602). In some cases, at least certain operations of the process 900 maybe performed by a separate computing system. Although one or moredifferent systems may perform one or more operations of the process 900,to simplify discussions and not to limit the present disclosure, theprocess 900 is described with respect to particular systems.

The process 900 may be performed automatically and without userinteraction. In some cases, a user or the subject 620 receiving therapyfrom the AMP 600 may trigger the process 900 via a command orinteraction with a user interface. However, once the process 900 istriggered, the process 900 may be performed automatically. In someexamples, the trigger may be a command received from an electronicdevice (e.g., an electronic device of a healthcare provider or atrainer, a cloud server or the like). Further, the trigger may be basedon the activation or first time use of the AMP 600 by the subject 620.

The process 900 begins at block 902 where the AMP 600 establishes acommunication connection with an electronic access device 806 or anelectronic evaluation device 802. The communication connection may beestablished over a wired or a wireless digital data link.

At block 904, the AMP 600 receives a passcode associated with a therapyaccess level from the electronic access device 806 or the electronicevaluation device 802. In some examples, the passcode may be atime-based passcode. In these examples the AMP 600 may also receive anindication of a validity period for the time-based passcode from theelectronic access device 806 or the electronic evaluation device 802. Insome examples, the AMP 600 may store the passcode in a memory 610 of theAMP 600.

At block 906, the AMP 600 may receive a request from the user or thesubject to access one or more therapy change controls associated withthe safe access level. The request may be a user interaction with atherapy change control element in a therapy change user interface menuof the AMP 600.

Once the request is received, at block 908, the AMP 600 may provide apasscode entry interface on a user interface of the AMP 600. In someexamples, the passcode entry interface may be a passcode entry userinterface in a main screen displayed on a touchscreen display of theAMP. In some other examples, the passcode entry interface may be a userinterface in a therapy change screen displayed on a touchscreen displayof the AMP 600. A user may activate the therapy change screen byinteracting with another user interface, such as a user interface thatreferences the therapy change screen.

At block 910, the AMP 600 may receive a user passcode from the user orthe subject. The AMP 600 may receive the user passcode via aninteraction with the passcode entry interface. In some examples, theuser may provide the user passcode using a physical keyboard or akeyboard displayed on a touchscreen display.

At decision block 912, the AMP 600 may determine whether the userpasscode matches with the passcode (e.g., a time-based passcode)received at block 904. Determining whether the user passcode matches thepasscode received at the block 904 may include comparing the twopasscodes. Comparing the passcodes may first include decrypting the userpasscode and comparing it to the stored passcode. Alternatively, or inaddition, the user passcode may first be hashed, and then the hasheduser passcode may be compared to the stored passcode. In some cases, theuse of hashing may be used to both determine that the passcodes matchand to determine that the user passcode has not been corrupted or isfree of errors.

If at decision block 912 it is determined that the user passcode doesnot match with the time-based passcode, the process proceeds to block914 where the AMP 600 maintains the unavailability of or does not permitaccess to the therapy change controls associated with the safe accesslevel. In some embodiments, at decision block 912, the AMP 600 maydetermine whether the user passcode is received during the validityperiod.

If at the decision block 912 the AMP 600 determines that the userpasscode matches with the passcode (e.g., time-based passcode) receivedand stored at block 904 (e.g., time-based passcode), at block 916, theAMP 600 provides access to the therapy change controls associated withthe safe access level. In some cases, when the passcode is a time-basedpasscode, at block 916 the AMP 600 may provide access to the therapychange controls if the user passcode is received during the validityperiod (as determined at decision block 912). If the user passcode isreceived after the validity period is expired, the user passcode may beignored. Alternatively, or in addition, a warning or error message maybe output indicating that the user passcode is expired or not valid.

In some examples, the access to the therapy change controls may beprovided by activating one or more therapy change control elementsavailable in a therapy change interface (e.g., a therapy change screendisplayed on a touchscreen display of the AMP 600). In some otherexamples, the user may first activate the therapy change interfacewithout using the user passcode. The therapy change interface mayinclude a plurality of therapy change control elements that areinactive. Upon user's interaction with one of the inactive therapychange control elements, a passcode entry interface may be provided onthe therapy change interface (block 908). In some such examples, atblock 916, one or more therapy controls from the plurality of thetherapy change control elements (e.g., those associated with the safeaccess level) may become active. In some examples, the therapy changecontrol elements may become inaccessible (e.g., become locked ordisappear from a touch screen display) after the validity periodassociated with the granted safe access level.

FIG. 10 is a flow diagram showing an example of a computer-implementedprocess 1000 that may be used by an AMP 600 to provide access to one ormore therapy change controls associated with a safe access level grantedto a user of the AMP 600 or a subject receiving therapy from the AMP 600using an access signal. The process 1000 may include one or morefeatures described with respect to process 900.

The process 1000 begins at block 1002 where the AMP 600 receives anindication that a safe access level has been granted to a user of theAMP 600 or a subject receiving therapy from the AMP 600. In someexamples, the granted safe access level may be a safe access levelselected by a healthcare provider or a trainer. In some other examples,the granted safe access level may be a safe access level determined byan electronic evaluation device 802. The indication can be a signal, ora message received from the electronic evaluation device 802, anelectronic access device 806, or another remote electronic device (e.g.,an electronic device of a healthcare provider or a trainer).

Upon receiving the indication, at block 1004 the AMP 600 establishes adigital data connection with an electronic access device 806 or anelectronic evaluation device 802. The digital data connection may beestablished over a wired or a wireless digital data link.

At block 1006 the AMP 600 receives an access signal associated with thesafe access level from the electronic access device 806 or theelectronic evaluation device 802. The AMP 600 may receive the accesssignal via a digital data interface. The digital data interface may bedigital interface of the communication system 622 of the AMP 600. Insome examples, in addition to the granted safe access level, the accesssignal may carry information about a validity period of the granted safeaccess level. In these examples, the validity period may be saved in amemory 610 of the AMP 600.

Upon receiving the access signal, at block 1008, the AMP 600 may provideaccess to the therapy change controls associated with the granted safeaccess level. Access to the therapy changes controls may be providedduring the validity period associated with the granted safe accesslevel. If the validity period is expired, access to the therapy changecontrols may be rescinded or denied. In some other examples, the accessto the therapy changes controls may be provided during the safe accessperiod associated with the granted safe access level. In yet otherexamples, the access signal may carry information that may be used bythe AMP 600 to determine whether to limit access to the therapy controlchanges for a validity period or particular time period associated withthe safe access level.

In some embodiments, at block 1008, the access to the therapy changecontrols may be provided by displaying one or more therapy changecontrol elements on a user interface (e.g., a touchscreen interface)provided by the user interface system 616 of the AMP 600. In some otherembodiments, the access to one or more therapy change controls may beprovided by unlocking one or more therapy change control elements in amenu displayed on a user interface provide by the user interface system616 of the AMP 600. The user or the subject may use the one or moretherapy change control elements to change the value of one or morecontrol parameters corresponding to the one or more therapy changecontrols. In some examples, the therapy change control elements maybecome inaccessible (e.g., become locked or disappear from a touchscreen display) after the validity period associated with the grantedsafe access level.

FIG. 11 is a flow diagram showing an example of a computer-implementedmethod that may be used by an electronic evaluation device to determinea safe access level for a user or a subject and provide access totherapy change controls associated with the safe access level. Theprocess 1100 may include one or more features described with respect toembodiments presented in FIG. 8A.

The process 1100 begins at block 1102 where the electronic evaluationdevice 802 receives a trigger to determine a safe access level for auser of the AMP 600 or a subject receiving therapy from the AMP 600. Asthe described above, the trigger may be a request received from anelectronic device (e.g., AMP 600, a cloud server, a personal electronicdevice of the user, a healthcare provides, or a trainer).

At block 1104 the electronic evaluation device 802 receives evaluationdata 802 for the user and/or the subject from an electronic device(e.g., AMP 600, a cloud server, a personal electronic device of theuser, a healthcare provider, or a trainer).

At block 1106, the electronic evaluation device 802 determines a safeaccess level for the user or the subject based on the evaluation data802 received at block 1104.

At block 1108, the electronic evaluation device 802 determines avalidity period for the safe access level during which the user maychange one or more control parameters associated with the determinedsafe access level. In some examples, the validity period may be includedin the request received at block 1102 and the process may omit theoperations associated with block 1108. In some other examples, the safeaccess profile associated with the safe access level may include a safeaccess period. In some such examples, the safe access period may be usedas the validity period.

At block 1110, the electronic evaluation device 802 generates atime-based passcode that expires at the end of the validity period. Insome embodiments, instead of a time-based passcode, the electronicevaluation device 802 generates and access signal associated with thedetermined safe access level. In some examples, in addition to thedetermined safe access level the access signal may carry informationabout the validity period of the determined safe access level.

At block 1112, the electronic evaluation device 802 establishes a datacommunication connection with the AMP 600.

At block 1114, the electronic evaluation device 802 transmits thetime-based passcode or the access signal to the AMP 600.

FIG. 12 is a flow diagram showing an example of a computer-implementedmethod that may be used by an electronic evaluation device to determinethe eligibility of a user of AMP 600 or the subject receiving therapyfrom the AMP 600 for a selected safe access level and providing accessto therapy change controls associated with the selected safe accesslevel.

The process 1200 may include one or more methods described with respectto embodiments presented in FIG. 8A.

The process 1200 begins at block 1202 where the electronic evaluationdevice 802 receives a request for determining the eligibility of theuser of the AMP 600 or the subject receiving therapy from the AMP 600,for a safe access level. In some cases, the request may be received fromthe AMP 600, a cloud server or a personal electronic device of the user,the subject, a healthcare provider or a trainer. In some other cases,the request may be received from an electronic device used by thehealthcare provider or the trainer. In some examples, the request mayinclude a validity period for the selected safe access level.

At block 1204, the electronic evaluation device 802 receives evaluationdata for the user or the subject from an electronic device through awired or wireless digital data link. In some examples, the evaluationdata may be stored in the electronic evaluation device 802. In some suchcases, operations associated with the block 1204 may be omitted oroptional.

At block 1206, the electronic evaluation device 802 determines theeligibility of the user or the subject for the selected safe accesslevel based at least in part on the received evaluation data at block1204 or the evaluation data stored in the electronic evaluation device802. If at block 1206 it is determined that the user or the subject isnot eligible, the process moves to block 1208 where the electronicevaluation device 802 rejects the request by not granting the selectedsafe access level to the user or the subject and notifies the requester(a healthcare provider, the user, the subject or the trainer) about therejection. For example, the electronic evaluation device 802 may send amessage (e.g., a text message) to the electronic device used to send therequest. In some examples, the message may include a reason forrejecting the request.

If at block 1206 it is determined that the user or the subject iseligible for the selected safe access level, the process moves to block1210 where the electronic evaluation device 802 generates a time-basedpasscode or an access signal. In some examples, at block 1206, the AMP600 may also determine a validity period for the selected safe accesslevel based at least in part on the evaluation data received at block1204. In some such examples, the determined validity period may be usedas the expiration time of the time-based passcode. In some otherexamples, the validity period may be encoded in the access signal.

At block 1212, the electronic evaluation device 802 establishes a dataconnection with the AMP 600. In some examples the digital dataconnection can be a wireless connection. In some other examples, thedigital data connection may be a wired connection. For examples, theuser or a healthcare provider may connect the AMP 600 to the electronicevaluation device 802.

At block 1214, the electronic evaluation device 802 transmits thetime-based passcode and its expiration time or the access signal to theAMP 600 over the digital data connection. In some examples, the AMP 600may provide access to the therapy change controls associated with theselected safe access level during the validity period, based on thetime-based passcode and its expiration time (e.g., using process 900) orbased on the access signal (e.g., using process 1000).

Enabling a Requested Glucose Level Therapy Control Configuration

In some examples, the AMP 600 may provide access to one or more therapychange controls associated with a safe access level using a passcodegenerated by an electronic passcode device and provided to a subject whoreceives therapy from the AMP 600 or to an authorized user of the AMP600. The safe access level may be the safe access level determined forthe user or the subject. The safe access level may be determined usingthe method described above with respect to FIG. 8A-FIG. 8C, process 1100or process 1200.

FIG. 13A shows a block diagram that represents an example system 1300 afor proving access to the therapy change controls associated with a safeaccess level using a passcode generated by an electronic passcode device1306.

In this example, the user or subject 1304 may initiate the process byrequesting access to one or more therapy change controls associated witha safe access level via a therapy change control request interface ofthe AMP 600. The therapy change request control interface can be part ofthe user interface (e.g., a touchscreen display) of the AMP 600. Forexample, the user may access the therapy change request controlinterface by selecting an item on a main menu or other menus generatedby the AMP 600 or by an electronic device connected to the AMP 600(e.g., using a user-interface interaction). In some cases, the therapychange request control interface may enable the user or subject 1304 toselect a group of therapy change controls associated with the safeaccess level or the safe access level. Selecting a therapy changecontrol or a group of therapy change controls (or a safe access level)by the user or subject 1304 may cause the AMP 600 to generate a devicepasscode 1320 b using a shared passcode algorithm 1318, establish a dataconnection (e.g., a wireless connection) with the electronic passcodedevice 1306, and send a passcode request to the electronic passcodedevice 1306 via the data connection. In some cases, data connection maycomprise Long-Term Evolution wireless connection, a Wi-Fi network, a 5Gcommunication network, a wide area network, a near-field communicationnetwork, or a short-range wireless electronic radio wirelesscommunication link

In some examples, the request message may comprise a device identifier.In some other examples, the message may at least comprise the deviceidentifier and the safe access level. The device identifier may be anyidentifier that can be used by the electronic passcode device 1306 touniquely identify the AMP 600. For example, the device identifier can bean IP address, a MAC address, or a serial number and the like.

Upon receiving the device identifier the electronic passcode device 1306may generate a user passcode 1320 a associated with the safe accesslevel based at least in part on the passcode request received from theAMP 600. In some embodiments, the electronic passcode device 1306 mayuse the device identifier received with the request message and theshared passcode algorithm 1318 to generate the user passcode 1320 a. Inthese embodiments, a copy of the shared passcode algorithm 1318 may bestored in a memory of the electronic passcode device.

In some cases, the electronic passcode device 1306 may generate thepasscode based on the request message and eligibility data received, forexample, from an electronic evaluation device (e.g., electronicevaluation device 802), a healthcare provider 812 or a trainer 814. Theelectronic evaluation device 802 can be the electronic device of ahealthcare provider 812 or a trainer 814. In some such cases, theelectronic passcode device 1306 may use the eligibility data to verifywhether the user or subject 1304 is eligible for the safe access level.If the electronic passcode device 1306 verifies that the user or subject1304 is eligible for the safe access level, it may generate the userpasscode 1320 a. The user passcode 1320 b may be provided directly tothe user or subject 1304 by an operator or administrator of theelectronic passcode device 1306 over a communication link (e.g., a wiredor wireless phone line). In some examples, the operator or theadministrator may provide the user passcode 1320 a via a voice call,voice message or text message. In some other examples, the electronicpasscode device 1306 may send the passcode via a text message to theuser's phone (e.g., a smart phone).

Upon receiving the user passcode 1320 a, the user or subject 1304 mayuse enter the user passcode 1320 a to AMP 600 using a passcode entryinterface (e.g., via an interaction with the passcode entry interface).Upon receiving the user passcode 1320 a from the user 1304, the AMP 600may compare the user passcode 1320 a with the device passcode 1320 b. Ifthe AMP 600 verifies that the user passcode 1320 a matches with thedevice passcode 1320 b, the AMP 600 may enable access to one or moretherapy change controls (associated with the safe access level) using,for example, procedures described above (e.g., with respect to process900 or process 1000).

In some embodiments, the user passcode 1320 a may be a time-basedpasscode and the eligibility data received by the electronic passcodedevice 1306 may include a validity period associated with theeligibility data received from the electronic evaluation device, aphysician or a trainer. In these embodiments, the access to the one ormore therapy change controls may be enabled only if the user passcode1320 a (e.g., a time-base passcode), is received during the validityperiod. Moreover, in these embodiments, the AMP 600 may terminate theaccess to the one or more therapy change controls at the end of thevalidity period.

In some examples, a glucose level control system of an ambulatorymedicament pump (AMP) or an ambulatory medicament device (AMD), mayprovide access to or enable a glucose level therapy controlconfiguration that may be associated with a safe access level using anaccess code received from an electronic configuration device. In someimplementations, the glucose control system may be a control system or acontroller of an AMP that provides glucose level control therapy to asubject. For example, the glucose level control system can be thecontroller 602 of the AMP 600. In some implementations, a glucose leveltherapy control configuration may be associated with specific values ofone or more control parameters of a control algorithm, a therapy controlinterface, a number of control parameters available in a therapy controlinterface, specific ranges or values associated with one or more controlparameters, a type of medicament that is administered to the subject,and other features that may be used to control and monitor medicamenttherapy delivery to the subject.

In some cases, providing access to or enabling a glucose level therapycontrol configuration may enable modification of a control algorithm(e.g., modification of one or more control parameters of a controlalgorithm) by the subject or the user of the glucose level controlsystem. Additionally, or alternatively, providing access to or enablingthe glucose level therapy control configuration may automatically modifyone or more control parameters of a control algorithm and thereby modifythe execution of the control algorithm. In some cases, providing accessto or enabling a glucose level therapy control configuration maygenerate or activate a new therapy control interface, add one or morecontrol parameters to a therapy control interface, remove one or morecontrol parameters to a therapy control interface, limit or expand anumber of selectable options/values for one or more control parameters,or add or remove features of a therapy control interface.

The electronic configuration device may generate the access code uponreceiving a unique identifier for an AMP and an identification of arequested modification or change to an initial or current glucose leveltherapy control configuration of the glucose level control system of theAMP. The unique identifier can include any type of identifier that canuniquely identify the AMP. For example, the unique identifier may be aserial number, unique code, or unique user account name associated witha user of the AMP. Further, the identification of the requestedmodification to the glucose level therapy control configuration may bereceived from any type of user, such as from the subject, a guardian ofthe subject, a trainer, a healthcare provider, and the like. Moreover,the requested modification may include an identity of one or morecontrol parameters to modify and/or obtain access.

The safe access level may indicate or specify the glucose level therapycontrol configuration that the user or subject is permitted to access.This safe access level may be one of a plurality of different safeaccess levels with each safe access level identifying different glucoselevel therapy control configurations. The electronic configurationdevice may determine a safe access level for the user or the subjectbased on evaluation data received from a healthcare provider, a trainer,an electronic evaluation device 802, or any other administrative user ordevice capable of evaluating the ability of the user or subject tooperate the AMP with a glucose level therapy control configurationassociated with the safe access level. In some cases, the electronicconfiguration device may determine the requested glucose level therapycontrol configuration based at least in part on the safe access levelfor the user or the subject. The requested glucose level therapy controlconfiguration may be a glucose level therapy control configuration thatcan be safely used by the user or the subject while managing thesubject's disease and/or maintaining the subject's health withinparticular health parameters, such as health parameters that may bedetermined by the subject's healthcare provider.

In some cases, the electronic configuration device may generate theaccess code. The electronic configuration device may provide the accesscode to the subject or the user of the ambulatory medicament pump, via adirect communication channel (e.g., a phone call, text message, email,voicemail, etc.) by an administrator, a healthcare provider, or atrainer. Additionally, or alternatively, the electronic configurationdevice may transmit the access code to the AMP via a wired or wirelessnetwork. For example, the electronic configuration device may transmitthe access code via a wireless LTE connection to the AMP.

FIG. 13B shows a block diagram that represents an example system 1300 bfor enabling a glucose level therapy control configuration of a glucosecontrol system 1312 of the AMP 600. The example system 1300 b includes:AMP 600 that provides medicament therapy to the subject and anelectronic configuration device 1308 that may be in communication withthe glucose control system 1312 of the AMP 600. Further, the electronicconfiguration device 1308 may communicate with the electronic evaluationdevice 802, one or more data repositories that may store subject'sinformation (e.g., granted safe access level data 1310, medical history,glycemic control record, and the like), or one or more electronicdevices (e.g., electronic devices of healthcare providers, or trainers).The electronic configuration device 1308 may have a user interface(e.g., a touchscreen display or a keyboard), that may be used to providedata to the electronic configuration device 1308 (e.g., subject'smedical data, information related to the AMP 600 and the like), orrequest service from the electronic configuration device 1308 (e.g.,reconfiguration request 1314).

In certain embodiments, the glucose control system 1312 may be or mayinclude one or more of the embodiments previously described with respectto the controller 602. The AMP 600 can be modified or controlled by theuser or subject 1304 via a user interface. A glucose level therapycontrol configuration of the glucose control system 1312 may beidentified or enabled using a secured access code (or an access code)generated by an electronic configuration device 1308. In some cases, theglucose level therapy control configuration may be associated with asafe access level granted to the user or the subject by another deviceor authorized individual. Further, the safe access level may bedetermined by the electronic configuration device 1308 before generatingthe access code.

FIG. 14 presents a flowchart of an example process 1400 for generatingan access code usable by a glucose control system 1312 of the AMP 600 tomodify or change a glucose level therapy control configuration of theglucose level control system in accordance with certain embodiments.

The process 1400 may be performed by the electronic configuration device1308. In some cases, the electronic configuration device 1308 may be acomputing system of a manufacturer, a healthcare provider, a trainer,the subject, or the user (e.g., a parent or guardian of the subject).The electronic configuration device 1308 may be a cloud-based computingsystem, a server, a desktop computer, a tablet, a laptop, a mobilecomputing system (e.g., a smart phone), or any other type of computingsystem that can evaluate a user to determine safe access levels for theuser and/or that can enable one or more glucose level therapy controlconfigurations of the AMP 600. In various embodiments, the electronicconfiguration device 1308 may at least include a non-transitory memoryconfigured to store specific computer-executable instructions, and ahardware processor in communication with the non-transitory memory andconfigured to execute the specific computer-executable instructions. Insome cases, an electronic configuration device 1308 can be or caninclude one or more of the embodiments described with respect to theelectronic access device 806 or the electronic evaluation device 802.

At block 1402, the electronic configuration device 1308 may receive areconfiguration request 1314 from the user, the subject, a healthcareprovider, or a trainer. The reconfiguration request 1314 may be anindication to modify a glucose therapy control configuration of theglucose control system 1312 to a requested glucose therapy controlconfiguration. An indication to modify a glucose therapy controlconfiguration may comprise a request to: change an initial or currentglucose therapy control configuration to the requested glucose therapycontrol configuration, enable modification of one or more controlparameters by the user or subject 1304, modify selectable values of oneor more control parameters, enable or disable a control interface,modify one or more control parameters, add or enable one or more controlparameters on a therapy control interface, remove or disable one or morecontrol parameters from a therapy control interface, limit or expand anumber of selectable options/values for one or more control parameters,or provide access to any other feature or configuration of the AMP thatenables the user to modify therapy provided by the AMP. In some cases,the electronic configuration device 1308 may determine the requestedglucose therapy control configuration based on the reconfigurationrequest 1314. In some cases, the reconfiguration request 1314 mayinclude an access period associated to a period during which the user orthe subject can use the requested glucose control therapy configuration.

In some cases, the electronic configuration device 1308 may receive thereconfiguration request 1314 via a user interface of the electronicconfiguration device 1308 (e.g., a keyboard, touch pad, touchscreendisplay, and the like). For example, a healthcare provider, the subject,or other authorized user may provide the reconfiguration request 1314 byinteracting with a keyboard or a touchscreen display of the electronicconfiguration device 1308. In some other cases, the electronicconfiguration device 1308 may receive the reconfiguration request 1314via a wired or wireless network connection. In some cases, theelectronic configuration device 1308 may receive the reconfigurationrequest 1314 from the AMP 600. For example, the subject 1304 may enterthe request using a user interface system 616 of the AMP 600. Therequest may then be transmitted by the AMP 600 to the electronicconfiguration device 1308.

In some cases, the reconfiguration request may include a uniqueidentifier for the AMP 600 that enables the electronic configurationdevice 1308 to uniquely identify the AMP 600 or the glucose controlsystem 1312. In some cases, the unique device identifier may be receivedfrom the AMP 600. The unique identifier may be a unique deviceidentifier, for example, an IP address, a MAC address, a serial number,a secret manufacturer code, a user account identifier, or any otherunique identifier that may be associated with the AMP 600. In somecases, the unique identifier may be stored in a database or other datastructure associated with or accessible by the electronic configurationdevice 1308. In some such cases, the reconfiguration request 1314 mayinclude information to identity the subject or user (e.g., a useraccount name or a unique user identifier). The electronicreconfiguration device may access the database to obtain a correspondingunique identifier for the AMP 600 based at least in part on the provideduser identifier.

At the decision block 1404, the electronic configuration device 1308determines or predicts the ability of the user or subject to safely usethe glucose control system 1312 when configured with the requestedglucose level therapy control configuration associated with thereconfiguration request 1314. For example, the electronic configurationdevice 1308 may determine or predict the ability of the user based onevaluation data 810 or granted safe access level data 1310 received froman external electronic device, the AMP 600 or a user interface of theelectronic configuration device 1308. Alternatively, or in addition, theelectronic configuration device 1308 may determine or predict theability of the user or the subject using an interactive evaluationprocess via a user interface of the electronic configuration device 1308or an intermediary electronic device.

In some cases, safe usage of the glucose control system 1312 maycorrespond to a usage of the glucose control system 1312 that does notresult in a deviation of a subject's glycemic control from a normalglycemic control for the subject. The normal glycemic control for thesubject may be a glycemic control determined by a healthcare provider ora physician. For example, a normal glycemic control may be a glycemiccontrol where subject's glucose level stays within one or more targetranges associated with different times of the day (e.g., morning,mealtime, afternoon, sleeping time and the like). Additionally, a normalglycemic control may be a glycemic control where a rate of change of thesubject's glucose level do not exceed a threshold value determined bythe physician or the healthcare provider. In some cases, a safe usage ofthe glucose control system 1312 may correspond to a usage of the glucosecontrol system 1312 that does not result in hyperglycemia orhypoglycemia in the subject.

In some implementations, the determination at the decision block 1404may be based on granted safe access level data 1310 associated with theuser or subject. The granted safe level access data may include dataassociated with a granted safe access level to the subject or the user.For example, the granted safe level access data may include a specificsafe access level of a plurality of safe access levels (e.g., safeaccess level G0 to G3, or T1 to T3 described above), an expiration datefor the granted safe access level and a unique identifier associatedwith AMP that provides medicament therapy to the subject or used by theuser. The electronic configuration device 1308 may receive the grantedsafe access level data 1310, via a wired or wireless connection, from anelectronic evaluation device 802, an electronic device of a healthcareprovider 812, or an electronic device of a trainer 814. In some cases,the electronic configuration device 1308 may receive the granted safeaccess level data 1310, via a wired or wireless connection, from anintermediary electronic device. In some cases, the granted safe accesslevel data 1310 may be received from a healthcare provider 812 or atrainer 814 via a user interface of the electronic configuration device1308. The granted safe access level data 1310 may be associated with theuser or the subject based on a unique user identifier that may be usedto uniquely identify the user or the subject. Further, in some cases,the granted safe access level data 1310 may include a unique identifier(e.g., a device ID) that uniquely identifies the ambulatory medicamentpump associated with the user or subject. The electronic configurationdevice 1308 may use the granted safe access level associated with theuser or subject to determine or predict whether the user or subject 1304can safely use the glucose level control system with the requestedglucose level therapy control configuration. In some cases, theelectronic configuration device 1308 may determine the requested glucoselevel therapy control configuration based on the granted safe accesslevel and/or the reconfiguration request 1314.

In some implementations, the electronic configuration device 1308 maydetermine or predict whether the user or subject 1304 can safely use theglucose level control system with the requested glucose level therapycontrol configuration associated with the reconfiguration request 1314,based on evaluation data 810 received from a computing system. Thecomputing system can be a cloud computing system, a server, a desktop,laptop, or tablet computer, a smart phone, or any other data repositorythat may store evaluation data. As mentioned above, evaluation data 810may include one or more prescriptions associated with the subject,training data, historical glycemic control data of the subject, dataassociated with the use of the glucose level control system by the userover an evaluation time period, and the like. The evaluation data 810may include the unique device identifier or information that uniquelyidentifies the ambulatory medicament pump. The evaluation data 810 mayalso include a unique user ID that may be used to uniquely identify thesubject or the user associated with the evaluation data.

As previously described, many categories of safe access levels may beavailable (e.g., category G, and category T), and each category may havedistinct levels (e.g., G0 to G3, or T1 to T3 described above),associated with a user's or subject's health condition and/or capabilityto use the therapy controls of the AMP. In some implementations, theelectronic configuration device 1308 may first use evaluation data 810to determine a specific safe access level for the user or subject 1304,and then use the safe access level, to determine or predict whether theuser or subject 1304 can safely use the glucose level control systemwith the requested glucose level therapy control configuration. In somecases, the electronic configuration device 1308 may use the evaluationdata 810 to directly analyze the user's health condition and ability touse therapy change controls based at least in part on the evaluationdata 810 and determine or validate the ability of the user or subject1304 to safely use the glucose level control system with the requestedglucose level therapy control configuration, without determining a safeaccess level for the user or subject 1304. For example, the electronicconfiguration device 1308 may determine whether the training datasatisfies a training threshold to validate the ability of the subject orthe user to safely use the glucose level control system with therequested glucose level therapy control configuration. As anotherexample, the electronic configuration device 1308 may use informationincluded in the one or more prescriptions associated with the subject tovalidate the ability of the subject or the user to safely use theglucose level control system with the requested glucose level therapycontrol configuration.

In some implementations, the electronic configuration device 1308 maydetermine or validate the user's capability to safely use the glucosecontrol system 1312 with the glucose level therapy control configurationassociated with the reconfiguration request 1314 using an interactiveevaluation process. The interactive evaluation process may include aninteraction with the user or the subject via one or more user interfacesof the electronic configuration device 1308 (e.g., a touchscreendisplay, a keyboard, a monitor, a mouse, an interactive softwareinterface, an interactive web page, and the like). For example, theinteractive evaluation process may include displaying a set of queries,corresponding to one or more use cases of the glucose level controlsystem, to the user and the receiving a set of responses to the set ofqueries. Subsequently, the electronic configuration device 1308 mayevaluate the set of responses to obtain an evaluation score and use theevaluation score to determine whether the user is capable of safelyusing the glucose level control system with the glucose level therapycontrol associated with the requested glucose therapy controlreconfiguration.

In some cases, the interactive evaluation process may include aninteraction of the user or the subject with one or more user interfaces(e.g., a touchscreen display, a keyboard, a monitor, a mouse, aninteractive software interface) of an electronic device that is incommunication with the electronic configuration device 1308 (e.g., via awired or wireless data connection). The electronic device may be the AMP600, an electronic device of the user or the subject (e.g., a computer,or a smart phone), an electronic device of a healthcare provider or atrainer, the electronic evaluation device 802, a cloud server or anyother electronic device that may support a user interface and cantransfer data between the user interface and the electronicconfiguration device 1308. For example, the user may interact with awebpage hosted by a server or cloud computing system that is incommunication with the electronic configuration device 1308. In someexamples, the electronic device may transmit the user inputs collectedduring the interactive evaluation process to the electronicconfiguration device 1308. In some examples, the electronic device maydetermine or validate the user's capability to safely use the glucoselevel control system 1312, based on the interactive evaluation process,and transmit the outcome to the electronic configuration device 1308.

If at the decision block 1404 the electronic configuration device 1308determines or predicts that user is not capable of safely using theglucose level control system when configured with the requested glucoselevel therapy control configuration, the process proceeds to block 1406where the process 1400 may be terminated. Alternatively, or in addition,the electronic configuration device 1308 may notify the user or subjectthat the reconfiguration request 1314 has been denied. In some cases,the user may be presented with an opportunity to modify the request orprovide an alternative request. The modified or alternate request may beprocessed using the process 1400. The notification may be a messagedisplayed on a user interface of the electronic configuration device1308, or a message sent to an electronic device of the user or subject1304 via a wired or wireless network connection. The message may includea reason for the request denial and/or may provide suggested permittedalternative configurations. Moreover, in some cases, the message mayindicate steps or actions the user or subject may perform to have therequest accepted. For example, the message may indicate that the requestis denied, but would be permitted if the user passed a particulartraining course.

If at the decision block 1404 the electronic configuration device 1308determines that the user or subject 1304 is capable of safely using theglucose control system 1312 with the requested glucose level therapycontrol configuration, the process proceeds to block 1408 where theelectronic configuration device 1308 generates an access code 1322 a forenabling or accessing the requested glucose level therapy controlconfiguration in the AMP 600.

The access code 1322 a may at least comprise access level data and theunique identifier associated with the AMP 600. In some examples, theaccess level data may be included in the reconfiguration request 1314.In some examples, the electronic configuration device may generate theaccess level data based on the received or the determined requestedglucose level therapy control configuration. The access level data mayinclude data associated with the one or more control parameters of acontrol algorithm. As mentioned above, the unique identifier may be aunique device ID (e.g., an IP address, a MAC address, or a serialnumber) that uniquely identifies the AMP whose glucose level therapycontrol configuration is modified or changed. Additionally, the accesscode may include a time-based value, which is described in more detailbelow.

In some embodiments, the access level data, may comprise a number or astring that encodes features (e.g., protected features) that may beenabled, disabled, or modified by the glucose level therapy controlconfiguration. In some cases, the access code may enable selectingspecified values or may remove limits on accessing values for one ormore control parameters. Alternatively, or in addition, the access codemay modify the default values of certain control parameters. The accesscode may be used to configure one or more optional features.

In some non-limiting example use cases, a portion of the access leveldata (which may be implemented as an encoded number or string) maycorrespond to a feature (e.g., Manual Bolus) and another portion maycorrespond to a state of the feature (e.g., on or off). Alternatively,or in addition, a portion of the access level data may correspond to acontrol parameter and another portion may correspond to a value of thecontrol parameter. In some non-limiting implementations, an access codemay comprise a 3-digit hexadecimal value where each digit may represent16 options or values (e.g., an off state and 15 values). In someimplementations, a 3-digit hexadecimal access code can be used to enablea glucose level therapy control configuration that is configured tomodify three protected features of the AMP: Manual Bolus, User Set Tmax,and Offset Targets. The first digit may be dedicated to the state of theManual Bolus, for example, 0 may indicate the OFF state and 1 mayindicate the ON state. The second digit may be dedicated to values ofthe User Set Tmax, where each hexadecimal symbol indicates two or moreselectable values or fixed new value; for example, 0 may indicate adefault value or default possible values, 1 may indicate 65 or 55, 2 mayindicate 45, 55 or 65, 3 may indicate 65 or 75 and 4 may indicate allpossible values. The third digit may be dedicated to Offset Targets; forexample, 0 may indicate an off state, 1 may indicate +1, 2 may indicate−1, 3 may indicate +2, 4 may indicate −2 and 5 may indicate +3. Itshould be understood that the aforementioned example use case is justone possible implementation of encoding a glucose therapy controlconfiguration. Other implementations for the format of the access leveldata and/or for the content of the access level data are possible.

In some cases, a new glucose level therapy control configuration mayrequire a new therapy control interface to be implemented by the AMP orthe controller of the AMP. In such cases, the safe access level data mayinclude information usable by the controller to implement the newtherapy control interface. For example, a digit of the hexadecimalstring may be dedicated to control interface types.

Additionally, the access code 1322 a may also comprise anerror-detection code such as a cyclic redundancy check (CRC), achecksum, a hash value, an error correction code, or a parity bit todetect inconsistencies or errors in the transmitted access code.

In some cases, the time-based value may correspond to a time periodduring which the access code 1322 a is valid and/or may be used toaccess the glucose level therapy control configuration associated withthe access code (e.g., the glucose level therapy control configurationdefined by the access level data). Alternatively, or in addition, thetime-based value may correspond to an access period during which therequested glucose level therapy control configuration associated withthe access code 1322 a, is available and may be used by the user toadjust one or more control parameters or modify the setting of the AMP.In some examples, the time period associated with the time-based valuemay be measured from a time at which the access code is first used,generated, or provided to the AMP 600. In some cases, the time-basedvalue can be a specific date and time. In yet other examples, thetime-based value may be associated with a number of times the requestedglucose level control configuration is used to adjust one or morecontrol parameters.

In some implementations, the electronic configuration device 1308 mayuse granted safe access level data 1310 or evaluation data 810 todetermine the time-based value for an access code corresponding to atime period during which the access code is valid. In some cases, theelectronic configuration device 1308 may determine the time-based valuebased at least in part on a prescription received or associated with asubject, training data associated with training by the subject, orinformation regarding a health condition of the subject. Theprescription, training data, or health information may be received bythe electronic configuration device 1308 and stored in a memory of theelectronic configuration device 1308. In some cases, the time-basedvalue may be provided to the electronic configuration device as part ofevaluation data 810, granted safe access level data 1310, therapycontrol configuration data, or a glucose therapy control configurationreconfiguration request 1314. In some cases, the electronicconfiguration device 1308 may generate the time-based value based on aseed value stored in the electronic configuration device 1308. The seedvalue may be also stored in the AMP 600 associated with the unique ID,for which the access code 1322 a is generated. The seed value mayinclude any type of value that may be used by two different devices togenerate the same value independently of each other and/or withoutexchanging information. For example, the seed value may be a currenttime as determined using an agreed upon time source (e.g., a time sourcespecified by the International Bureau of Weights and Measures). Asanother example, the seed value may be a synchronous counter that isshared by the electronic configuration device 1308 and the AMP 600. Theseed value may be applied to an algorithm used in common by theelectronic configuration device 1308 and the AMP 600 to generate ashared value (e.g., the time-based value). In some embodiments, the seedvalue may be a shared or negotiated value that is negotiated between theelectronic configuration device 1308 and the AMP 600. In some cases, theseed value refers to a particular algorithm rather than a singularvalue.

At block 1410, the electronic configuration device 1308 may use theaccess code 1322 a generated at block 1408 to generate a secured accesscode 1322 b. In some cases, a security manager 1316 may generate thesecured access code 1322 b using one or more encryption or hashingalgorithms. In some implementations, electronic configuration device1308 may encrypt the access code to generate the secured access code1322 b. Various symmetric or asymmetric encryption algorithms may beused for encrypting the access code including, for example, IDEA, MD5,HMAC, TripleDES, Blowfish, Twofish, DES, 3DES, AES, RSA, ECC, and thelike.

In some other implementations, the electronic configuration device 1308may generate the secured access code by hashing the access code 1322 a.Various hash algorithms may be used for hashing the access code forexample, MD5, SHA-1, SHA-2, SHA-3, BLAKE2, BLAKE3, RIPEMD-160,Whirlpool, SHA1 and the like. In some cases, different portions of theaccess code 1322 a (e.g., safe access level data, unique ID, ortime-based value) may be hashed separately with different hashingalgorithms.

At block 1412, the electronic configuration device 1308 may output thesecured access code 1322 b via a user interface. In someimplementations, the secured access code 1322 b may be provided to anadministrator 1302, a healthcare provider, a trainer, or anyone who isauthorized to help manage care of the subject (e.g., a parent or aguardian of the subject). In some examples, the electronic configurationdevice 1308 may provide the secured access code 1322 b to the user via awired or wireless phone line (e.g., as a voice or text message). In somecases, the electronic configuration device 1308 may directly provide thesecured access code to the AMP 600 over a wired or wireless networkconnection.

The electronic configuration device 1308 may provide the secured accesscode 1322 b (e.g., the encrypted or the hashed access code) bydisplaying it on a display of the electronic configuration device 1308.In some cases, the electronic configuration device 1308, may send thesecured access code 1322 b to the user or subject 1304, or otherauthorized individuals via a wired or wireless network connection (e.g.,as an e-mail, text message or the like).

Once the secured access code 1322 b (or the access code 1322 a) isreceived by the subject or the user, the subject or the user may providethe secured access code 1322 b to the glucose control system 1312 via anaccess code entry interface (e.g., a touchscreen display, or a keyboard)of a user interface system 616 of the AMP 600. Alternatively, or inaddition, the electronic configuration device 1308, may transmit thesecured access code 1322 b over a wired or wireless network connection(e.g., an LTE) to the AMP 600 (to the glucose control system 1312 of theAMP 600). In some cases, the electronic configuration device 1308, maytransmit the secured access code 1322 b to an electronic intermediarydevice (e.g., a smart phone, a laptop or desktop, computer, asmartwatch, and the like) over a wired or wireless connection (e.g.,LTE, 5G, Bluetooth®, etc.) and the electronic intermediary device maytransmit the secured access code 1322 b to the AMP 600.

In some implementations, instead of the secured access code 1322 b, theelectronic configuration device 1308, may provide the access code 1322 a(generated at block 1408) to the subject, user, or other authorizedindividual using one or more of the methods mentioned above with respectto providing the secured access code 1322 b. In these implementations,block 1410 in the process 1400 may be eliminated.

FIG. 15 presents a flowchart of an example configuration activationprocess 1500 for enabling or activating a requested glucose leveltherapy control configuration of the glucose control system 1312 of theAMP 600 using a secured access code 1322 b (or an access code 1322 a).The activation of the requested glucose level therapy controlconfiguration may modify or enable modification of a control algorithmof the glucose level control system based on a safe access level for auser of the AMP 600. The process 1500 may be performed by the glucosecontrol system 1312 of the AMP 600.

At block 1502 the glucose control system 1312 may receive a securedaccess code from a user interface (e.g., in response to a userinteracting with the user interface), or a wired or wireless connectionto an electronic configuration device (e.g., via the communicationsystem 622).

At block 1504 the glucose control system 1312 may retrieve or validatethe access level data, unique identifier, and/or the time-based valueencoded in the secured access code 1322 b (or access code 1322 a). Insome cases, the glucose control system 1312 may use a security manager1316 to retrieve the access level data, unique identifier, and/or thetime-based value using the secured access code 1322 b. For example, thesecurity manager 1316 may execute a decryption algorithm to decrypt thesecured access code 1322 b and extract the access level data, uniqueidentifier, and/or the time-based value. In some implementations, thesecured access code 1322 b is encrypted using a public key of the AMP600 or a shared secret shared between the electronic configurationdevice 1308 and the AMP 600. In some such cases, the security manager1316 may decrypt the secured access code 1322 b using a private keystored in a secure memory location of the glucose control system 1312.In some examples, the security manager 1316 may use a decryptionalgorithm used by the electronic configuration device 1308 to encryptthe access code 1322 a.

In some cases, at block 1504 the glucose control system 1312 may use thesecurity manager 1316 to validate the secured access code 1322 b using ahashing algorithm (e.g., the hashing algorithm used to generate theaccess code 1322 b), a second access level data, a second uniqueidentifier, and/or a second time-based value stored in the memory 610 ofthe controller 1312. In some cases, the second access level data and thesecond time-based value may be associated with the reconfigurationrequest 1314. For example, the second access level data may beassociated with the requested glucose therapy control configuration andthe second time-based value may be associated with a period during whichthe requested glucose therapy control configuration will be available.In some examples, the security manager 1316 may use the hashingalgorithm, used to generate the secured access code 1322 b, to validatethe second access level data, the second unique identifier, and/or thesecond time-based value based on secured access code 1322 b.

In some implementations, the glucose control system 1312 may use thehashing algorithm to hash the second access level data, the secondunique identifier, and/or the second time-based value stored in thememory 610 of the glucose control system 1312 to generate a secondhashed value. The hashing algorithm used by the glucose control system1312 may be the same hashing algorithm used to generate the securedaccess code 1322 b. Subsequently, the glucose control system 1312 mayvalidate the secured access code 1322 b by comparing the second hashedvalue and the secured access code 1322 b. In some implementations, thesecond access level data, the second unique identifier, and/or thesecond time-based value are hashed separately. In some such cases, eachhashed value is compared to a corresponding hashed value included aspart of the secured access code 1322 b. Upon validating the securedaccess code 1322 b, the glucose control system 1312 may access the safeaccess level data, unique identifier, and/or the time-based value.

In some cases, the glucose control system 1312 may use an errordetection code to determine whether the access code is error free. Ifthe glucose control system 1312 determines that the access code includeserrors, it may determine whether the access code can be recovered fromthe detected error.

At decision block 1506 the glucose control system 1312 may determinewhether a unique identifier retrieved (e.g., decrypted) from the securedaccess code 1322 b (or the access code 1322 a) matches with a secondunique identifier stored in the memory 610 of the glucose control system1312. Alternatively, if at block 1504 the unique identifier is validatedusing the secured access code 358 b (e.g., by hashing the secured accesscode and the second unique identifier), block 1504 may be omitted andthe process moves to decision block 1510.

If at the decision block 1506 the glucose control system 1312 does notverify that the unique identifier matches with the second uniqueidentifier, the process may proceed to block 1508 where theconfiguration activation process 1500 is terminated. Upon termination ofthe process, the glucose control system 1312, may notify the user (e.g.,via a user interface of the AMP 600) or the subject that the receivedaccess code is not associated with the AMP 600 used by the user or thesubject.

If at the decision block 1506 the glucose control system 1312 verifiesthat the unique identifier matches with the second unique identifier,the process may proceed to the decision block 1510 where the glucosecontrol system determines whether the time-based value retrieved atblock 1504, is valid or expired. In some cases, the glucose controlsystem 1312 may determine whether the time-based value retrieved atblock 1504, is valid or expired by comparing the time-based value to asecond time-based value generated at the glucose level control system.Alternatively, if at the decision block 1504 the time-based value isvalidated using the secured access code 1322 a (e.g., by hashing thesecured access code and the second time-based value), block 1510 may beomitted and the process moves to block 1514.

If at the decision block 1510 the glucose control system 1312 verifiesthat the time-based value is not valid (e.g., it is expired or does notmatch with the second time-based value), the process may proceed toblock 1512 where the configuration activation process 1500 isterminated. Upon termination of the process, the glucose control system1312, may notify the user (e.g., via a user interface of the AMP 600) orthe subject that the received access code is expired.

If at the decision block 1510 the glucose control system 1312 verifiesthat the time-based value is valid, the process may proceed to the block1514 where the glucose control system 1312 determines a requestedglucose level therapy control configuration using the access level dataretrieved at block 1504 or the second access data validate at the block1504. As mentioned above, the requested glucose level therapy controlconfiguration may identify a new therapy control interface, a controlparameter to include in a therapy control interface, the controlparameter to enable in the therapy control interface, a controlparameter value for the control parameter, a new control algorithmfunctionality for the control parameter, or any other feature that maymodify therapy or control of therapy at the AMP. In some cases,implementation of the requested glucose level therapy controlconfiguration may require an update to or a new version of thecomputer-executable instructions or control software associated with anexisting glucose level therapy control configuration. For example, ifthe requested glucose level therapy control configuration identifies anew therapy control interface, a new control software may need to beinstalled to provide access to the new therapy control interface. Asanother example, if the requested glucose level therapy controlconfiguration identifies a new control algorithm or a new controlalgorithm functionality, a new set of instructions (e.g., a newapplication, or a new software) may be needed to support the newfunctionality or to implement the new control algorithm.

At decision block 1516, the glucose control system 1312 may determinewhether the requested glucose level therapy control configurationrequires a software or application update. The glucose control system1312 may analyze the access level data extracted from the receivedaccess code to determine the need for updating an application. Theapplication update can be a new version of an existing application, areplacement or substitute application, or an application patch. Theapplication update may include a binary executable file that may beexecuted by the processor of the glucose control system 1312.

If at the decision block 1516 the glucose control system 1312 determinesthat the requested glucose therapy control configuration does notrequire a new software update or installation, the process may move toblock 1520.

If at the decision block 1516 the glucose control system 1312 determinesthat the requested glucose therapy control configuration requires a newapplication or software update or installation, the process may move toblock 1518 where the glucose control system 1312 downloads and/orinstalls the required application update. In some cases, upondetermining that an application update is needed, the glucose controlsystem may notify the user or the subject, that an application has to beupdated in order to enable the requested glucose control therapyconfiguration determined based on the access code (the access level dataextracted from the access code). In some cases, the user notificationmay include an application code/name/version and/or a server or hostfrom which the application update can be downloaded.

In some cases, the application update may be stored in a host computingsystem separate from the glucose control system 1312. In some cases, theapplication update may be stored in a memory 610 of the glucose controlsystem 1312. In some cases, the host computing system may be theelectronic configuration device 1308. In some cases, the applicationupdate may be pushed or transmitted to the host computing system by theelectronic configuration device 1308. In some implementations, theglucose control system 1312 may update an application executing on theambulatory medical device without interrupting, or while causing minimalinterruption, to therapy provided by the AMP 600 to the subject. In someimplementations, the glucose control system 1312 may automaticallydownload and update an application based on one or more methodsdescribed in U.S. patent application Ser. No. 17/062,356 the contents ofwhich are hereby incorporated by reference in its entirety herein andmade a part of the present application. In some implementations, theuser may download and/or install the application update usinginstructions included in the user notification.

In some cases, the new application or application update may be neededto enable new features of a requested glucose therapy controlconfiguration not supported by the glucose controller prior to receivingthe access code.

At block 1520, the glucose control system 1312 may enable or activatethe requested glucose level therapy control configuration. Onceactivated, the requested glucose level therapy control configuration mayallow the user or the subject to modify the values of one or morecontrol parameters that were not previously available for the user tomodify or to modify beyond a certain range before activating therequested glucose level therapy control configuration. In some cases,activation of the requested glucose level therapy control configurationmay limit or stop the access to one or more control parameters of acontrol algorithm. In some cases, activation of the requested glucoselevel therapy control configuration may disable or enable a feature ofglucose control system 1312. In some examples, upon activating arequested glucose therapy control configuration, the glucose controlsystem 1312 may notify the user and show the new available features, newparameter control ranges, new parameters that can be controlled,eliminated features, parameters that can not be modified anymore and thelike, on a display of the AMP 600.

In various embodiments, the glucose control system 1312 may allow theuser or the subject to revert the glucose control system 1312 to aglucose therapy control configuration used before activating therequested glucose level control configuration. In some cases, the usermay need a revert code to revert back the requested glucose levelcontrol configuration. The revert code may be generated and provided tothe user or the subject by the electronic configuration device 1308using one or more of the systems and methods described above withrespect to FIG. 13A and FIG. 13B.

In certain embodiments, the glucose control system 1312 may revert theglucose control system 1312 to a glucose therapy control configurationused before activating the requested glucose level control configurationafter an expiration condition is satisfied. In some cases, the glucosecontrol system may determine that an expiration condition has beensatisfied based on: an expiration time period measured from the time atwhich the requested glucose level control configuration has beenactivated, an expiration date, a number of administrations of medicamentafter activating or enabling the requested glucose level controlconfiguration, or a number of adjustments made to one or more controlparameters after activating or enabling the requested glucose levelcontrol configuration. In some cases, the expiration time period or theexpiration date may be associated with the time-based value extractedfrom the secured access code or the access code.

In some cases, one or more features of a requested glucose therapycontrol configuration may have different expiration conditions. Eachfeature of the requested glucose therapy control configuration may ceasebeing accessible after its corresponding expiration condition issatisfied.

In certain embodiments, the glucose control system 1312 may revert theglucose control system 1312 to a glucose therapy control configurationused before activating the requested glucose level controlconfiguration. The glucose control system 1312 may revert the glucosecontrol system 1312 to a prior glucose therapy control configurationupon receiving a command or signal from a remote computing system, or inresponse to an expiration condition. The remote computing system may bethe electronic configuration device 1308 or a computing system of ahealthcare provider, a manufacturer, or a trainer.

In some cases, the changes and adjustments made by the user or thesubject using a newly activated requested glucose therapy controlconfiguration may result in hypoglycemia, hyperglycemia, an abnormalbehavior of the subject's glucose level, or a degradation of subject'sglycemic control. In some such cases, the glucose control system 1312may automatically revert the glucose control system 1312 to a glucosetherapy control configuration used before activating the requestedglucose level control configuration.

As mentioned above, upon evaluating the ability of the user to safelyuse the glucose level control system with a requested glucose leveltherapy control configuration, the electronic configuration device 1308may change an initial glucose level therapy control configuration to therequested glucose level therapy control configuration. The electronicconfiguration device 1308 may allow the user to use the requestedglucose level therapy control configuration during an access period withthe time-based value retrieved from the access code (e.g., the securedaccess code 1322 b).

In some implementations, the user may extend the access period bysending an access period extension request to the electronicconfiguration device 1308 (e.g., via wired or wireless connection or auser interface). In some cases, extending the validity period mayrequire re-evaluating the ability of the user to safely use the glucoselevel control system with the requested glucose level therapy controlconfiguration. In some cases, the re-evaluation process may not involvethe physician, the healthcare provider or the trainer. For example, uponreceiving the access period extension request from the user, theelectronic configuration device 1308 may re-evaluate the user's abilityto safely use the requested glucose level control system based on theuser's use of one or more therapy controls associated with the requestedglucose level therapy control configuration during the access period.For example, the electronic configuration device 1308 may determinewhether changes made by the user to the one or more therapy controlparameters, associated with the requested glucose level therapy controlconfiguration, resulted in hypoglycemia or hyperglycemia during theaccess period. If the electronic configuration device 1308 determinesthat user's use of therapy controls associated with the requestedglucose level therapy control configuration during the access period didnot result in hypoglycemia or hyperglycemia, it may allow the user touse the requested glucose level therapy control configuration during anextended access period. In some cases, the electronic configurationdevice 1308 may also use the evaluation data 810, which may have beenupdated during the access period, in the re-evaluation process. In somecases, the electronic configuration device 1308 may use the interactiveevaluation process described above to re-evaluate user's ability tosafely use the requested glucose level control system during an extendedaccess period. In some cases, if the electronic configuration device1308 determines that user's use of therapy controls associated with therequested glucose level therapy control configuration during the accessperiod resulted in periods or hypoglycemia or hyperglycemia, it may denythe access period extension request and notify the user that the accessperiod may not be extended (e.g., via a user interface of the AMP 600 ora user interface of the electronic configuration device 1308).

In some embodiments, a user may request access to a glucose leveltherapy control configuration that was previously requested. Regardlessof whether the prior request was granted or denied, the user may bereevaluated to determine whether user can safely operate the AMP whenconfigured with the requested glucose level therapy controlconfiguration. In some cases, re-evaluation of the user may be based atleast in part on new evaluation data. For example, a history ofoperation of the AMP may be used to reevaluate the user. The history ofoperation may include data that was not previously available during aprior request to access the glucose level therapy control configuration.The subsequent request to access the glucose level therapy controlconfiguration may occur during or shortly after use of the AMP with theglucose level therapy control configuration as part of a request forre-authentication to use the glucose level therapy controlconfiguration. In some cases, the subsequent request to access theglucose level therapy control configuration may occur at some time afterexpiration of a prior granting of access to the glucose level therapycontrol configuration.

Software Update of Ambulatory Medical Device

It is often the case that a computer application is updated after it isreleased. In some cases, the application is updated to patch bugs orvulnerabilities. In other cases, the application is updated or replacedwith a new version to introduce new features or improve existingfeatures. Regardless of the reason, it is often the case that anapplication is shutdown or is not executing while the application isupdated. For most applications, there is minimal to no harm in shuttingdown or not executing an application while it is updated or otherwisereplaced. For example, it is inconsequential that a video game, wordprocessing, or edutainment application is not executing while it isupdated.

However, it can be inconvenient, harmful, or, in some cases,life-threatening to cause an application on an ambulatory medical deviceto cease executing while it is updated or replaced by a new version ofthe application. If a subject or subject that is receiving therapy fromthe ambulatory medical device enters a state where therapy is desired orneeded while an application or control software of the ambulatorymedical device is being updated or replaced, harm may occur to thesubject. For example, suppose the ambulatory medical device is aninsulin pump, such as those that may be used by a type-1 diabetic. Ifthe insulin pump becomes inoperative due to a software update processoccurring at a time when a subject's blood glucose level exceeds aset-point or target range, the user may not receive a necessary insulinbolus from the ambulatory medical device. Thus, it is desirable tomodify reduce or eliminate disruption to subject care or therapy whenupdating applications, such as control software, of an ambulatorymedical device.

In some embodiments, an ambulatory medical device includes acomputer-implemented method of updating an application executing on theambulatory medical device without interrupting, or while causing minimalinterruption, to therapy provided by the ambulatory medical device to asubject or subject. The method may generally be performed by a hardwareprocessor, (e.g., a controller, and the like), included in an ambulatorymedical device and based on a set of instructions that may be stored,for example, in a non-transitory memory of the AMD. The applicationupdate may be a new version of the application, a replacement orsubstitute application, or an application patch. In some examples, theapplication may be an older version of the application that has beenused by instances of the ambulatory medical device for more than athreshold period of time and has experienced less than a thresholdnumber of faults. The application update may be stored in one or morehost computing systems. The application update may be pushed to the hostcomputing systems by a company that manages or manufactured theambulatory medical device or other software company that is authorizedby the manufacturer or licensee of the device.

FIG. 16 is a flow diagram showing an example of a computer-implementedmethod that may be used by the AMD in order to detect and download anapplication update from a host computing system or other computerreadable media in which a copy of the application update is stored. Incertain aspects, an ambulatory medical device, such as a medicamentdelivery device or a medicament pump may receive an indication 1602 thatan update is available for an application, such as control software orother software that controls or facilitates the operation of theambulatory medical device. The software update may include a binaryexecutable file for various processors of the ambulatory medical device.In some embodiments, the indication may be a determination made by asoftware or hardware module included in an ambulatory medical device ofAMD. For example, the AMD may access a particular host computing system(e.g., using its communication module) to determine whether an update isavailable, based on set of update trigger conditions stored in a memoryof AMD. The set of update trigger conditions may be defined/changed by auser and/or received by AMD from a host computing system. For example, atrigger condition may push the AMD to periodically search for an updateat time intervals set by the user or received from a host computingsystem. Alternatively, or in addition, in response to a trigger (such asa user command, the replacement of medicament within the ambulatorymedical device, the connecting to a particular network, or theconnecting to a network using a particular communication transceiver(e.g., Wi-Fi) or the like), the ambulatory medical device may access aparticular host computing system to determine whether an update isavailable to an application installed on the AMD. The software to beupdated on the AMD may be currently executing on the ambulatory medicaldevice or may be executed in future.

In some embodiments, the indication may be a query received from thehost computing system that may access the AMD to read and compare thesoftware versions and/or the hardware configuration (and/or warranty) todetermine the eligibility of the ambulatory medical device for asoftware upgrade. The serial number, the model number, and/or thesoftware version may be used to determine software upgrade eligibility.In some embodiments, the eligibility may be determined based on thegeoposition of the device and/or whether the device is connected to alocal area network (such as for example, a Wi-Fi network) or a wide areanetwork (such as, for example, a cellular network). In variousembodiments, the ambulatory medical device may have an antenna thatprovides the device with GPS, text or picture messaging, telephonecalling, and data transfer capabilities. Software update may be providedon a limited release with test groups of varying sizes, e.g., 1-100 or1-1000 or 1-10000. There may be a phased rollout of the softwareupdates. In some embodiments, the AMD may respond to an upgradeeligibility request with a version of the first software or a modelidentification information of the ambulatory medical device or amanufacturing date of the ambulatory medical device.

If it is determined that an update is available to the applicationexecuting on the ambulatory medical device, the ambulatory medicaldevice may establish a connection 1604 to a host computing system thathosts the update to the application. Such connection may be establishedvia one or more links or methods discussed above, such as with referenceto FIG. 7.

Once a connection is established, the ambulatory medical device maydownload the application update or application update from the hostcomputing system over the connection 1606. In some examples, theambulatory medical device may download an image of the applicationupdate from the host computing system. While the application update isbeing downloaded, an existing version of the application on theambulatory medical device may continue to execute. Thus, there is littleor no interruption to therapy provided by the ambulatory medical devicewhile the application update is being obtained by the ambulatory medicaldevice.

Once the application update is obtained, the ambulatory medical device(using its control and computing module) may perform one or moreoperations to confirm that the application update was successfullydownloaded from the application host system and that the download wasnot corrupted 1608. For example, the ambulatory medical device maycalculate a hash or checksum value from the downloaded applicationupdate. This hash or checksum value may be compared with one receivedfrom the application host system. If the calculated hash or checksumvalue matches the received hash or checksum value, then it may bedetermined that the download is both complete and not corrupt. Further,the ambulatory medical device may use the checksum, a tag, a payloadsize, or any other method to confirm that the download of theapplication update is complete and not corrupt. If it is determined thatthe download is corrupt 1608, the AMD discards the corrupt copy anddownloads another copy of the update 1606. If it is determined that thedownload is complete and not corrupt, the AMD may proceed to theinstallation step 1610 wherein the application update may be installedon the AMD without interrupting the ongoing or upcoming therapysessions.

FIG. 17-FIG. 19 are flow diagrams illustrating examples ofcomputer-implemented methods that may be used by the AMD to install adownloaded application update without disrupting the therapy provided toa subject.

In the example method illustrated in FIG. 17, if it is verified that anuncorrupted copy of the update for an application is successfullydownloaded 1702 (e.g., using the procedure described above withreference to FIG. 16), the control and computing module (CCM) of the AMDmay determine the amount of time required to install the applicationupdate 1704 and wait for a trigger signal 1706 to initiate installationprocess. In some examples, the CCM may notify to the user 1708 through auser interface (e.g., a touchscreen display), that an update is readyfor installation. The notification may include the installation time andinformation about the update. In such examples, if a trigger is notreceived, CCM may send one or more notifications to the user indicatingthat a new update is ready for installation. In some examples, thetrigger may be the confirmation that the application was successfullydownloaded. Alternatively, or in addition, the trigger may be a usercommand received based on an interaction by a user or subject with auser interface that is part of or that communicates with the ambulatorymedical device.

The installation time may be determined by the CCM based on data ormetadata provided with the downloaded application update. For example,the application update may include a file (e.g., a text file orconfiguration file) that includes the install time. The installationtime may be determined by the manufacturer of the ambulatory medicaldevice or the publisher of the application update. For example, thedeveloper of the software update may average the install time acrossseveral test devices to determine the install time metadata that isprovided with the software update. General purpose computers have a widevariety of configurations and the performance of a general purposecomputer may vary depending on the applications executing at aparticular time. Thus, the determination of install time for anapplication based on the measurement of install time on a test device istypically unreliable. However, as an ambulatory medical device is oftena special-purpose device that is designed to perform a specific function(e.g., provide insulin to a subject), an install time determined duringtesting by a manufacturer may in many cases be a reliable determinationof install time on an ambulatory medical device of a subject.Alternatively, or in addition, to determining the install time based ontesting by a manufacturer, the install time of an application update maybe determined or estimated based on a size of the application update. Insome cases, the provided or estimated install time may include a buffer.In other words, an additional amount of time may be added to the installtime to account for variances in operating condition of the ambulatorymedical device or inaccuracies in the estimated install time.

If a trigger is received 1706, the CCM may check for any ongoing therapysession 1710. If the no therapy is currently being administered, the CCMdetermines the next therapy time 1714 (or the time left until the nexttherapy session). If therapy is currently being administered theinstallation will be delayed 1712 until the therapy session is compete.Once the current therapy session is complete, the CCM may determine thetime remaining until next therapy session 1714 (e.g., during whichmedicament, such as insulin is delivered to a subject).

In some cases, the determination of the next time that therapy is to bedelivered may be an estimate based on historical delivery of therapy, apresent condition of the subject (e.g., when a glucose level is of asubject is at the center of a desired range, the next therapy deliverytime may be estimated to be further off than when the glucose level isat the edge of the desired range), and/or an indication provided by auser or subject (e.g., an indication that the user is planning to have ameal, to exercise, or to go to sleep). Alternatively, or in addition,the determination of the next time that therapy is to be delivered maybe based on a scheduled delivery of therapy (e.g., every 5 minutes orevery hour).

As previously described, it is desirable to prevent disruption totherapy during the application update process. Thus, after the nexttherapy time is determined 1714, the estimated install time may becompared 1716 to the determined or estimated next therapy delivery timeto determine whether the installation of the application update can becompleted before the next therapy delivery to the subject. If it isdetermined that the time left until the next therapy session issufficiently longer than the determined time for completing theinstallation, installation of the application updated may be initiated1718. In some examples, the determined time to the next therapy sessionhas to be longer than the determined installation time by a thresholdvalue. Such threshold value may be different for different applicationupdates and/or the type of next therapy session. If it is determinedthat the application installation cannot be completed before the nexttherapy delivery (or the time left until the next therapy is not largerthan that estimated installation time by a threshold value), theinstallation of the application may be delayed, regardless of receipt ofthe trigger. In this case, the CCM may wait for the next therapy to becompleted and then determine a new therapy time 1714. This process maybe repeated until CCM determines that the update can be installedwithout interrupting an expected or scheduled therapy by the ambulatorymedical device. In some examples, a new determination may be made beforecompletion of the next therapy, to determine whether installation may becompleted prior to a subsequent therapy time after the next therapytime.

In some cases, a time when the application can be installed withoutinterrupting therapy may not be identified. In some such cases, a user(e.g., a clinician or other medical provider, or a subject) may beprovided with an alert that an application update is available and/orthat the application update cannot be installed without interruptingtherapy. The user may be provide with an option as to whether to permitthe update and/or when to install the application update. The option mayinclude presenting the user with the estimated install time enabling theuser to schedule the application update at a time when interruptions totherapy may be minimal or when an alternative source of therapy (e.g.,injection therapy) can be utilized.

In some embodiments, once it is verified that an uncorrupted copy of theupdate for an application is successfully downloaded 1702, the AMD'scontrol and computing module (CCM) may notify the user and wait for atrigger signal before determining the installation time. Once thetrigger has been received, the CCM initiates the installation process ofthe downloaded copy of the application update without interruptingtherapy provided by the ambulatory medical device to the subject. Insuch embodiments, the application update may be installed in a differentmemory location than the memory location where the original applicationis installed and executed.

FIG. 18 is flow diagram illustrating an example of acomputer-implemented method that may be used by the AMD in order toinstall a second application that is an update to a first applicationexecuting on the ambulatory medical device, without disrupting thetherapy provided to a subject. In this example, once the control andcomputing module (CCM) of the AMD verifies that an uncorrupted copy ofthe second application is successfully downloaded 1802 (e.g., using theprocedure described above with reference to FIG. 16), the CCM mayinitiate the installation process of the second application 1804 withoutinterrupting the execution of the first application. The CCM may confirm1806 the successful installation of the second application and wait fora trigger signal 1810 to initiate the execution of the secondapplication in place of the first application. In some examples, theinstallation of the second application may be confirmed by sending anotification the user 1808 via a user interface of the AMD. In someexamples, the CCM may determine the amount of time required forswitching the control of AMD to from the first application to the secondapplication. The notification may include information about the updateand the time required for switching between the applications. In someexamples, the trigger may be a user command received based on aninteraction by a user or subject with a user interface that is part ofor that communicates with the ambulatory medical device. In suchexamples, if a trigger is not received the AMD may send one or morenotifications to the user indicating that a new update is ready forinstallation. If a trigger is received, the CCM may check for anyongoing therapy session 1812. If the no therapy is currently beingadministered, the CCM determines the next therapy time 1816 (or the timeleft until the next therapy session). If therapy is currently beingadministered the installation will be delayed 1814 until the therapysession is compete. Once the current therapy session is complete, theCCM may determine the time remaining until next therapy session 1816.The estimated next therapy delivery time may be compared to a setthreshold time to determine whether the switching from the firstapplication to the second application can be performed withoutinterfering with the next therapy session. If it is determined that thetime left until the next therapy session is longer than the setthreshold time 1818, the execution of the second application will beinitiated and the execution of the first application will be halted1820. In some examples, the set threshold time may be determined by theCCM at least partly based on the time required to execute of the secondapplication and halt the first application. In some other examples, theset threshold time may be received from a host computing system.

In some embodiments, the performance of an application update may betested before switching control of the AMD to the application update.FIG. 19 illustrate an example method that may be used by suchembodiment. First the AMD verifies that an uncorrupted copy of theupdate for a first application is successfully downloaded 1902 (e.g.,using the procedure described above with reference to FIG. 16). Next theAMD may install 1904 and execute 1906 the downloaded copy of the secondapplication without interrupting the execution of the first applicationand therefore the therapy that might be provided by the ambulatorymedical device to the subject. In some examples, the second applicationupdate may be installed to a separate portion (e.g., a separateexecution space or separate memory) from the portion where the firstapplication is installed and is being executed. The Control andcomputing module (CCM) of the AMD may determine that a minimum set ofoperating conditions 1908 are satisfied by the second application 1910,wherein the minimum set of operating conditions relate to maintainingtherapy provided by the ambulatory medical device to the subject. If itis determined that the minimum set of operating conditions are notsatisfied by the second application, the AMD may wait for an indicationthat a third application is available 1912 and repeat the proceduredescribed above to evaluate the performance of the third application. Ifit is determined that the minimum set of operating conditions aresatisfied by the second application, the AMD may check for an ongoingtherapy session 1914. If it is determined that currently no therapy isprovided to a subject, CCM may switch the control of the ambulatorymedical device from the first application to the second application1918. If currently therapy is provided to a subject, the CCM may waituntil the therapy session is competed 1916 and then switch the controlof the AMD from the first application to the second application.

In some cases, the ambulatory medical device may be updated (ordowngraded) to add (or remove) features from the ambulatory medicaldevice. For example, the ambulatory medical device may initially provideonly insulin therapy. At some point in time, the ambulatory medicaldevice may be upgraded to include bi-hormonal control (e.g., to provideboth insulin therapy and counter-regulatory agent (e.g., Glucagon)therapy). The upgrade may be based on newly available features and/orbased on a decision by a user to purchase or otherwise obtain additionalfeatures. Similarly, a user may opt to downgrade therapy frombi-hormonal to insulin-only therapy. Alternatively, the upgrade ordowngrade may be made based on the availability of medicament. In someexamples, a first update can be a first application version comprising afirst feature set (e.g., providing insulin therapy) and a second updatecan be a second application version comprising a second feature set(e.g., provide both insulin therapy and Glucagon therapy). In some suchexamples the first feature set may comprise a subset of the secondfeature set. In some other examples, the first feature set may comprisea partially overlapping set of features with the second feature set.

In some examples a computer-implemented method that may be used by theAMD in order to detect, download and install an update to an applicationexecuting on the ambulatory medical device wherein the applicationcomprises one of a first application version comprising a first featureset or a second application version comprising a second feature set. Insome examples, the first feature set may comprise partially overlappingset of features with the second feature set. In some other examples, thefirst feature set may comprise partially overlapping set of featureswith the second feature set. The AMD may receive an indication ofavailability of the application update, download the application updateand verify that an uncorrupted image of the application update issuccessfully downloaded (e.g., using the procedure described above withreference to FIG. 16). Next, the control and computing module (CCM) ofthe AMD may initiate the installation process of the application updateimage without interrupting the execution of the application. In someexamples, the indication received by the AMD 1602 (with reference toFIG. 16), may include information about application update being anupdate to the first application version or to the second applicationversion. In some such examples, the CCM may determine the version of theapplication update and download the application update image based onthe determined version

In some embodiments, any downloaded application update may be installedto a separate portion (e.g., a separate execution space or separatememory) from a currently executing version of the application. Onceinstallation of the application is complete and the application isverified as being successfully installed, the active version of theapplication can be switched. For example, control of the ambulatorymedical device can be provided to the updated application, thepreviously executing application can be ceased or halted. The oldapplication can then be removed, or kept as backup. Determining when toswitch which version of the application is active may follow a similarprocess as previously described for identifying a next therapy deliverytime and selecting a time to switch active versions of the applicationwhen there will not be an interruption to the therapy provided by theambulatory medical device.

In some embodiments, the ambulatory medical device may be configured tostore multiple instances of an application (e.g., ambulatory medicaldevice control software). For example, the ambulatory medical device mayhave a current, or first, version of the application that it isinstalled in a first memory location (e.g., in the memory 610) and isexecuting to, for example, control therapy provided by a subject.Further, the ambulatory medical device may include an updated, or secondversion of the application installed in a second memory location (e.g.,in the memory 610). The update of the second version may have beendownloaded and installed (e.g., in a prior to detection of the fault).In such embodiments, when a fault is detected during execution of thefirst version of the application, the ambulatory medical device mayinitiate the execution of the second version of the application and thenswitch control of the AMD to the second version of the application tomaintain therapy to the subject.

In some examples, the second version of the application installed on theAMD may be a version older than the first version, or version that maynot have track a record of stability and reliability. FIG. 20 is a flowdiagram for such examples. Once an application-fault is detected duringexecution of the first version 2002, the control and computing module(CCM) of the AMD may switch the control of the AMD to the second versionof the application 2004 while establishing a connection with a hostcomputing system configured to host a third update and download thethird update 2006. The third version of the application may be a newversion, a version prior to the first version, an update to the firstapplication that addresses the detected application-fault or an olderversion that satisfies the conditions to be classified as a “safeversion” (e.g., less than a threshold number or rate of faults over aminimum period of time). The second version (installed in the device)may control the AMD while the third version is being downloaded andinstalled 2008 without interrupting the therapy. Once the download ofthe third version is complete, the CCM may initiate the installationprocess of the downloaded copy of the third application and switchcontrol of the ambulatory medical device form the second application tothe third application 2010 without interrupting therapy provided by theambulatory medical device to the subject

In yet other embodiments, a “safe version” of the application may havebeen installed on the ambulatory medical device prior to detection of afault. The safe version of the application may include a version of theapplication that has been used by instances of the ambulatory medicaldevice for more than a threshold period of time and has experienced lessthan a threshold number of faults. For example, the safe version of theapplication may be a two-year old version of the application that hasdemonstrably had less than a threshold number of faults occur over theperiod of two years. This safe version of the application may have lessfeatures than the first or second version of the application. However,when a fault is detected during execution of the first or second versionof the application, the ambulatory medical device may switch control ofthe device to the safe version of the application to maintain therapy tothe subject.

In some cases, if there is an issue installing an updated version of theapplication, the ambulatory medical device may revert to the currentversion or a safe version installed on the AMD.

In some other examples, the AMD may be triggered to establish aconnection with the host computing system and search for the secondversion once a fault is detected during execution of the first version.In these examples, the ambulatory medical device may revert to the safeversion (installed in the device) while downloading and installing thesecond version without interrupting the therapy.

FIG. 21 is a flow diagram illustrating yet another example of a methodof responding to a fault detection by the AMD. In this example, once anapplication-fault is detected during execution of the first version ofan application 2102, the control and computing module (CCM) of the AMDmay look for a second version of the application 2104 in the main memoryor the storage. If it is determined that the second version has beenalready downloaded, the CCM will determine 2106 whether the secondversion of the application is installed in a memory location and isready to be executed. If it is determined that the second version of theapplication is installed, the control of the AMD will be switched to thesecond version of the application 2108. With reference to block 2106, ifCCM determines that the second version exists in the memory but it isnot installed, it will switch the control of the AMD to a safe versionthat may be already installed 2116 and then initiates the installation2118 of the second version. Once the installation of the second versionis complete, the CCM may switch control of the AMD from the safe versionof the application to the second version of the application. In someembodiments, after the control of the AMD is switched to the secondversion of the application, the CCM may search for a third version ofthe application 2110 that may be an update to the previously downloadedsecond version. If a third version is found, the CCM may download andinstall the third version 2112 and switch the control of the AMD to thethird version 2114. With reference to block 2104, if the CCM cannot finda second version of the application in a memory or storage location, itwill switch the control of the AMD to a safe version of the application2120 that may be installed in a memory location (e.g., in the mainmemory or in the storage) and then search for a third version of theapplication 2110. If a third version is found, the system may downloadand install the third version 2112 and switch the control of the deviceto the third version 2114.

In some embodiments, when an application-fault of an applicationexecuting on the ambulatory medical device is detected, the AMD maytransmit an indication of the application-fault to the host computingsystem of a manufacturer or maintenance service of the ambulatorymedical device. In some other embodiments, the AMD may notify the userwhen an application-fault occurs through a user interface of the AMD oruser interface communicating with the AMD.

Direct Network-Connected Medical Device Communication and Remote Viewing

An ambulatory medical device, such as an ambulatory medicament device(e.g., blood glucose control system (e.g., an insulin pump or abi-hormonal pump that includes insulin and a counter-regulatory agent),a pacemaker, or any type of medical device that may be connected to asubject to provide therapy to the subject, can generate a significantamount of data related to therapy provided to a subject (therapy data).This therapy data may be useful for the subject, a healthcare provider,or other users (e.g., parent or guardian) to actively manage thesubject's health condition. For example, the therapy data may be usefulto determine whether a modification to therapy may be desirable or toconfirm that intended therapy is being delivered at the right time. Inother examples the data may be used to generate an alerts about thehealth condition of the subject when therapy data indicates thatimmediate attention is needed with regards to subject' health condition.

Various aspects of accessing the therapy data or other types of datastored in a memory of the AMD needs proper management in order toprovide uninterrupted, secure and easy access to authorized users. Asdescribed above, the procedures and task performed by an AMD, includingthose associated with data transfer management, may be associated withcertain computer-executable instructions stored and executed by acontrol and computing module of the AMD. As such, different AMDconfigurations used for various data transfer management tasks, may beconfigurations of the control and computing module of the AMD.

Accessing the data from the ambulatory medical device can be problematicin some cases. For example, accessing the data may require a user toconnect the ambulatory medical device to a computer to upload the data.This places a burden on the user to remember to connect the ambulatorymedical device. Further, during the period when the device is connectedto the computer, the subject may not be receiving therapy from theambulatory medical device. In some cases, the subject may not be capableof connecting the device to the computer (e.g., when the AMD is notwithin range of the local device) and may not have someone available toassist the subject. Thus, a direct end-to-end connection to a computingsystem that (e.g., computing system of a healthcare provider) can safelyshare data (e.g., therapy data) with authorized users may facilitatedata management and access.

FIG. 22 is a block diagram illustrating an example network configurationwherein the AMD 2202 is directly connected to a computing system 2206 inaddition to environmental sensors 2204 and medical sensors 2208. Thecomputing system 2206 may be part of networked computing environment2212 (e.g., a data center, networked computing system), or cloud network2210 or cloud computing system of a cloud service provider. Thecomputing system may include one or more non-transitional memories andone or more hardware processors configured to execute thecomputer-executable instructions stored in one or more non-transitionalmemories. In some such examples, the procedures performed by thecomputing system may be associated with the execution of certaincomputer-executable instructions stored in a memory of the computingsystem by a hardware processor of the computing system.

In some examples, the direct end-to-end data connection may be supportedby one or more transceivers in a communication module of the AMD (e.g.,the communication system 622 of FIG. 6). For example, a directconnection may be established between the AMD 2202 and the computingsystem 2206 over a wide area network (e.g., a cellular network) withoutusing an intermediary system using various wireless standards andtechnologies (e.g., 4G, 5G and the like). In some examples, thetransceiver may support communication via communication standards,including but not limited to, low power wide area network (LPWAN),Narrowband Long-Term Evolution (NB-LTE), Narrowband Internet-of-Things(NB-IoT), or Long-Term Evolution Machine Type Communication (LTE-MTC).In some cases, the transceiver is always on, and in other cases, thetransceiver may be activated when a data transfer is scheduled,requested or activated. In some cases, the capability of the ambulatorymedical device 2202 to communicate with the computing system may beactivated during manufacture or before providing the device to asubject.

In some cases, the subject or a user establishes or initiatesestablishing the direct end-to-end data connection with the computingsystem. For example, the subject may interact with a user interface tocause the ambulatory medical device to communicate with the cloudcomputing service. In other cases, the direct end-to-end data connectionmay be initiated or established without action by the subject or theuser. For example, the direct end-to-end data connection may occurautomatically at particular times or when the ambulatory medical deviceis in particular locations. This automatic connection may occur usinginformation supplied to the ambulatory medical device at a time ofmanufacture, shipment, sale, or prescription to the subject. Further, insome cases, the ambulatory medical device can communicate with thecomputing system without having access to a wifi network or a local areanetwork (LAN). For example, the ambulatory medical device maycommunicate using a cellular or other wide area network. Further, insome cases, the interaction by the user with the ambulatory medicaldevice may be relatively minimal or simple compared to traditionalnetwork communication. For example, a user may push a single button(e.g., an “upload” button) to trigger establishing of a connection withthe cloud computing service and causing data to be provided from theambulatory medical device to the cloud computing service.

In some cases, the ambulatory medical device may be turned on and pairedwith the wireless wide area network (e.g., a cellular network) at thetime of manufacture, or prior to being provided to a subject. Further,the ambulatory medical device may be authenticated with thenetworked-computing environment as part of the manufacturing process

Further, establishing the direct end-to-end data connection may includedetermining that the ambulatory medical device is permitted tocommunicate with the computing system based at least in part on thedevice identifier.

In some implementations, establishing the direct end-to-end dataconnection may include determining that the ambulatory medical device ispermitted to communicate with the computing system based at least inpart on a device identifier associated with the ambulatory medicaldevice. The device identifier may be a unique identifier specific to theambulatory medical device. The device identifier may include or may bebased on one or more of an Internet Protocol (IP) address, a MediaAccess Control (MAC) address, a serial number, or a subject identifierof a subject that receives therapy from the ambulatory medical device.

Further, establishing the direct end-to-end data connection may includedetermining that the ambulatory medical device is permitted tocommunicate with the computing system based at least in part on thedevice identifier. The device identifier may be initially provided tothe networked-computing environment prior to provisioning of theambulatory medical device to the subject. For example, the deviceidentifier may be initially provided to the networked-computingenvironment as part of a manufacturing process for manufacturing theambulatory medical device. The request may include a device identifierassociated with the ambulatory medical device.

The ambulatory medical device may be configured to at least identify acomputing system 2206 of a networked computing environment 2212 based ona whitelist of one or more approved computing systems. The whitelist maybe stored in a memory of the AMD 2202 (e.g., a memory in the control andcomputing module of the AMD). Further, the whitelist may be configuredduring manufacture of the ambulatory medical device. For example, thewhitelist may be configured with connection information to establishcommunication with one or more computing systems of anetworked-computing environment. Further, the ambulatory medical devicemay be configured to at least obtain an address of the computing systemfrom the whitelist and to establish a direct end-to-end data connectionto the computing system of the networked-computing environment via awireless wide area network using the address. The whitelist may includeunique identifiers, such as MAC addresses or static IP addresses thatare associated with computing systems of the cloud services provider.

To enhance security, the ambulatory medical device may use a whitelistthat identifies via a unique identifier (e.g., via an IP address, a MACaddress, or a URL) permitted cloud servers or computing systems innetworked computing environment. Further, the cloud computing servicemay have a whitelist that uses unique identifiers to specify ambulatorymedical devices and/or other computing systems (e.g., remote displaysystems) that are permitted to communicate with the cloud computingsystem.

When the AMD communicates data over a network, there is a risk of a databreach. Thus, to improve security, all communication between theambulatory medical device and the computing may be based on a securedata transmission method. For example, the ambulatory medical device mayencrypt all data using an asymmetric key.

In some examples, the therapy data may be encrypted before beingtransferred to the computing system. In these examples, AMD may have apublic key and a private key stored in one of its memories permittingthe AMD to encrypt data communications transmitted by the ambulatorymedical device to the computing system. In these examples, AMD maytransmit the public key along with the therapy data to the computingsystem. The public key provided by the AMD and a private key stored onthe computing system may permit the computing system to decrypt the datareceived from the ambulatory medical device. In some such cases, thepublic key may timeout and a new public key may be obtained from theambulatory medical device to facilitate decrypting subsequentcommunications from the ambulatory medical device. In some cases, thepublic key may be associated with a time-to-live (TTL) value. In somesuch cases, the public key may timeout and a new public key may beobtained from the ambulatory medical device to facilitate decryptingsubsequent communications from the ambulatory medical device.

Moreover, the secure data transmission may include generating a sharedsecret based at least in part on the public key and the private key. Insome such cases, decrypting the encrypted data comprises using theshared secret to decrypt the encrypted data. In some examples, sharedsecret may be established using public key exchange algorithm (e.g.,Diffie-Hellman key exchange algorithm).

In some cases, the computing system may be configured to transfer thedata after receiving a request to transfer data stored on the ambulatorymedical device to the computing system over the direct end-to-end dataconnection via the wireless wide area network. Responsive to receivingthe request to transfer data stored on the ambulatory medical device tothe computing system, the computing system may be configured to receive,via the direct end-to-end data connection.

Once a connection is established and the therapy data is transferred tothe computing system, the computing system may analyze the therapy datareceived from the ambulatory medical device and generate a therapyreport. Further, the computing system may detect an alarm condition,based on therapy data analysis, and generate an alarm that may beprovided to the subject, authorized user (e.g., healthcare provider). Insome cases, the therapy data may trigger an automatic response by thecomputing system. For example, the AMD may determine that a medicamentor another disposable is running low based on the received data and mayautomatically reorder the medicament or the disposable.

In some cases, the computing system may periodically receive data fromthe ambulatory medical device based on a regular schedule.Alternatively, or in addition, the data may be received in response to acommand or when the ambulatory medical device determines it is within acertain location. For example, when the ambulatory medical devicedetermines it is within a subject's home or at a healthcare provider'soffice based on a local area network connection or based on ageolocation system (e.g., a global positioning system (GPS)). In someimplementations, additional encrypted data is received from theambulatory medical device on an intermittent basis. Alternatively, or inaddition, additional encrypted data is received from the ambulatorymedical device on a continuous basis for at least a time period. Theambulatory medical device may be configured to transmit data as it isgenerated, or shortly thereafter, (e.g., in real or near real-time(e.g., within a few millisecond, seconds, or minutes of the data beinggenerated)), or in bulk at specified periods of time. Transmitting thedata in bulk at particular time periods may extend battery life, but mayprovide for less up-to-date analysis. Data can be made availableon-demand by keeping the transceiver always on, but this may consumemore power. Thus, the scheduling of data transfer may be balanced basedon different considerations, such as: (1) power consumption and (2) needto share information with authorized users or systems.

In some cases, the computing system may be used as a backup for theambulatory medical device. For example, the ambulatory medical devicecan backup data to the computing system every night, when it ischarging, or when it is in proximity to home or a physician's office(e.g., when subject is in waiting room, the device may upload data thatthe physician can then access). Moreover, if the ambulatory medicaldevice is replaced (e.g., for a new model or to replace a damageddevice), the device can automatically synchronize with the computingsystem to obtain subject-specific configuration or therapy control data.

Therapy Data and Therapy Report

In some examples, the therapy data comprises dose or dosage datacorresponding to one or more doses of medicament provided by theambulatory medical device to the subject. Further, the therapy data maycomprise subject data corresponding to a medical or physiological stateof the subject as determined by the ambulatory medical device.

In other examples, the data provided to computing system may include anytype of data that may be measured or obtained by the ambulatory medicaldevice and may include a record of therapy provided by the ambulatorymedical device. For example, the data may include a time that therapywas provided, an amount of medicament provided as part of the therapy, ameasure of one or more vital signs of the subject, a measure of bloodglucose levels at different times for the subject, a location of thesubject, and the like.

In some cases, the therapy data may be used to track the use ofdisposables, such as insulin or other medicament, or insulin pump sitekits. In some cases, the computing system may automatically order orreorder disposables at a particular time based on tracking the use ofthe disposable. Alternatively, or in addition, the reordering of thedisposables may be initiated or performed from the ambulatory medicaldevice (e.g., via a wireless wide area network or via a local connectionthrough a separate electronic device).

In some cases, the data transferred to the computing systems maycomprise operation data corresponding to operation of the ambulatorymedical device. Alternatively, or in addition, the data may furthercomprise error data corresponding to an error in operation of theambulatory medical device.

In some examples, the data, therapy data and/or the therapy report maybe stored in a memory of the computing system and/or at a storage of thenetworked-computing environment.

In some cases, the method may include converting the therapy data fromone format to another format. For example, the method may includeconverting the therapy data from a format used to store and/or presentdata on ambulatory medical device to a format that can be stored orprocessed on the computing system. In some cases, the therapy data isconverted from a machine-readable format to a human-readable format. Thedata may be stored in a more easily interpreted format that can beunderstood by different types of users. For example, the data may bepresented in one format for a healthcare provider (e.g., sensorreadings), a simplified format for a subject or parent of a subject,other data formats for displaying data to different types of users.

In some examples, the therapy data collected from different AMDsassociated with plurality of subjects may be aggregated for a group ofsubjects based on their association with an institution or organization(e.g., a clinic, an insurance company, and the like)

In some other examples, a therapy report based at least in part on thetherapy data may be generated by the computing system. The therapyreport may comprise time-series therapy data relating to the therapydelivered by the ambulatory medical device over a particular timeperiod.

In some examples, the therapy report may be sent to AMD wherein thesubject can see the report via a user interface (e.g., a touchscreendisplay).

In some cases, the ambulatory device data and/or data generated by thecomputing system based on the ambulatory device data can be viewed on asecondary display system from the computing system. For example, aclinician or parent can access the data from their personal device. Thecommunication between the computing systems and the viewing device maybe encrypted. Moreover, permission for sharing of end user data with a‘follower’ (e.g., family member) or clinician may be granted orcontrolled by the end user (e.g., the subject or a guardian).

An association between a subject, a clinic, and/or an ambulatory medicaldevice may be performed by association of a device serial number of theambulatory medical device with the subject and/or clinic. Further, auser (e.g., a subject, clinician, or parent) can access therapeuticrecommendations through the cloud in case either the ambulatory medicaldevice (e.g., an insulin pump) or the CGM sensor fails to function.

In some cases, the computing system may be configured to at leastreceive a request from one or more display systems 2214 that areseparate from the networked computing environment to access the therapyreport, therapy data or other data received by or stored in the AMD. Insome cases, the display system may be a computing system of a medicalpractitioner 2218 (e.g., such as a doctor, nurse, . . . ), a guardian ofthe subject 2220 (e.g., subject's parents), an authorized user 2224(e.g., a user authorized by the subject such as spouse, relative,friend, and the like), a health care service provider 2222, or a deviceof the subject 2216 (e.g., cell phone, personal computer, tablet and thelike).

In some examples, the display system can be a therapy data managementsystem that analyses a therapy data associated with a specific typehealth problem (e.g., data associated with managing diabetes) andprovides useful information to the subject or an authorized user tomonitor and manage the corresponding ailment.

The request may comprise an account identifier associated with a userthat generated the request. In some examples, the account identifier maycomprise a unique identifier associated with the subject. Alternatively,or in addition, the account identifier comprises a unique identifierassociated with a user that is authorized to access the therapy report.The user may or may not be the subject. In some aspects of the presentdisclosure, the method may further include associating the therapy datawith the account identifier at a storage of the networked-computingenvironment. Further, the computing system may be configured todetermine whether an account associated with the account identifier ispermitted to view the therapy report. In some examples, accountpermissions may be granted and/or modified by the subject. For example,the subject can access an account at a networked computing environment2212, for example, a cloud service provider associated with the subject,and provide one or more identifiers associated with one or more otherusers to give them permission to access the subject's therapy data orreport stored on the computing system.

Responsive to determining that the account is permitted to view thetherapy report, the hardware processor may be configured to transmit thetherapy report to the display system over an encrypted communicationchannel.

In some cases, the method may include receiving an identity oridentification information of one or more users that are authorized toaccess therapy data stored at the networked-computing environment. Forexample, a user or subject may authorize a clinician or other healthcareprovider, a parent or guardian, or other users that the subject desiresto have access to the therapy data. The identity information of the oneor more users may include any type of information that may identify theuser or enable the user to be authenticated. For example, the identityinformation may include a name, unique identifier (e.g., social securitynumber), an email, an address, a phone number, account information forthe user at the networked-computing environment, or any otheridentifying information.

FIG. 23 is a flow diagram that illustrates an example method that may beused by computing system 2206, to generate and share a therapy reportbased on encrypted therapy data received from an AMD 2202. In someexamples, the AMD 2202 may generate the encrypted therapy data using apublic key and a private key. The method may include establishing adirect end-to-end data connection 2302 to an ambulatory medical device,for example, via a wireless wide area network (WAN) using a NarrowbandLong-Term Evolution (NB-LTE) transceiver included in the AMD 2202. Oncea direct end-to-end data connection between the AMD 2202 and thecomputing system 2206 is established, the computing system may receive apublic key 2304 (e.g., associated with encrypted data), from the AMD2202 over the established connection. Next, the computing system mayreceive a request from the AMD 2306 to transfer data (e.g., therapydata) stored on the AMD 2202 to the computing system 2206 over thedirect end-to-end data connection. In some examples, the computingsystem 2206 may use the device ID associated with the AMD 2202 todetermine whether the AMD 2202 is authorized to transfer data to thecomputing system 2308. If, based on the device ID, it is determined thatthe AMD 2202 is authorized to transfer data to the computing system, theencrypted therapy data may be transferred 2312 to the computing system.If, based on the device ID, it is determined that the AMD 2202 is notauthorized to transfer data to the computing system, the request may bedenied 2310. The computing system may decrypt the encrypted therapy data2314 using a private key (e.g., stored in a memory of the computingsystem) and a public key received from the AMD 2202. In some examples,the therapy data may be used to generate a therapy report 2316. In someexamples, the decrypted therapy data and/or therapy report may be storedin a memory of the computing system 2206.

The example method may further include receiving a request from adisplay system 2214 that is separate from the networked computingenvironment, to access the therapy report 2318. The request may comprisean account identifier associated with a user that generated the request.The method may include determining using the account identifier todetermine whether the account associated with the account identifier ispermitted to view the therapy report 2320. In the computing systemdetermines that the account associated with the received accountidentifier does not have the required permission, the request will bedenied 2324. Responsive to determining that the account is permitted toview the therapy report, the method may include transmitting the therapyreport to the display system 2322 over an encrypted communicationchannel.

In certain implementations, the method may further include determiningthat the therapy data or other data received from the AMD satisfy analert threshold condition. In these implementations, it is determinedthat the therapy data or other data received from the AMD satisfy analert threshold condition, the computing system may send an alert to oneor more display systems designated to receive alerts from the computingsystem.

In some examples, alert threshold condition may be associated with thehealth condition of the subject. For example, alert threshold conditionmay include subject's blood sugar level is above or below a set value(hyperglycemia or hypoglycemia). In some other examples the alertthreshold condition may be associated with the operation of the AMD. Forexample, alert threshold condition may include the rate of therapy(e.g., the rate at which insulin is provided to a subject) being aboveor below a set value.

In some other examples, alert threshold condition may be associated withthe temporal behavior of therapy data over a period of time. Forexample, the alert threshold condition may include the fluctuations orvariations of the subject's blood sugar level being above a set value.

In some examples, the alert threshold condition may be defined or set byhealth provider. In some such examples, the health provider may changeone or more alert threshold conditions based on the health condition ofthe subject.

FIG. 24 is block diagram, illustrating an example network and data flowconfiguration where an AMD 2402, which is directly connected to acomputing system 2406 (e.g., computing system within a cloud network2410), may generate and send alerts 2416 (e.g., alert messages, alertsignals and the like) upon determining that data 2412 received from theAMD satisfies a threshold condition. The computing system 2406 may bepart of networked computing environment 2414 (e.g., a data center,networked computing system), or cloud network 2410 or cloud computingsystem of a cloud service provider. The computing system may include oneor more non-transitional memories and one or more hardware processorsconfigured to execute the computer-executable instructions stored in oneor more non-transitional memories. The AMD may receive data from one ormore medical sensors 2408 (e.g., analyte sensor, temperature sensor,heart beat sensor, and the like) and/or one or more environmentalsensors (e.g., geolocation receiver, motions sensor, accelerometer andthe like.). These sensors may be included in the AMD unit or may beconnected to the AMD via a wired or wireless link.

In some cases, the display systems receiving the alert 2420, may bedisplay systems that have already received therapy reports from thecomputing system 2406. In other examples, a group of display systems maybe selected and authorized by the subject, who is receiving therapy fromthe AMD, to receive alerts 2420. The display systems that may receivealerts 2420 from the AMD may include: a medical practitioner 2424 (e.g.,such as a doctor, nurse, . . . ), a guardian of the subject 2426 (e.g.,subject's parents), an emergency service provider 2428, an authorizeduser 2430 (e.g., a user authorized by the subject such as spouse,relative, friend, and the like), a healthcare provider 2432, or a deviceof a subject 2422 (e.g., cell phone, personal computer, tablet and thelike). In some examples, when it is determined that received data 2412the AMD satisfies a threshold condition, in addition to sending a alertsto one or more display systems 2418, the computing system 2406 may sendan alert 2416 to the AMD 2402.

In some examples, the AMD 2402 may be configured to establish aconnection to support continuous data transfer to the computing system2406 for a given period of time (e.g., provided to the AMD by thesubject), in order to capture any data that is generated over thatperiod and satisfies an alert threshold condition. For example, thesubject may request a continuous connection between AMD and thecomputing system when going for hike alone to make sure that if his/herhealth condition deteriorate during the hike, an alert is sent toauthorized display systems.

In some examples, a geolocation sensor (e.g., a Global PositioningSystem (GPS) receiver) and/or a proximity sensor can be used to enablelocation-activated features such as automatic upload of data at certainlocations.

In some cases, the ambulatory medical device may include or be connectedto an accelerometer or a geolocation system. This velocity of theambulatory medical device may be determined based at least in part onthe accelerometer or geolocation system. Using the data obtained 2412from the ambulatory medical device 2402 including the location and/orvelocity information, the computing system 2406 can provide intelligentalerts. For example, if the data indicates that a user is travelling ata high rate of speed (e.g., likely in a car) and the user's bloodglucose level is low (e.g., below 55 mg/dl), the computing system mayautomatically alert emergency service providers 2428 that a subject isat risk of hypoglycemia and may be driving. Further, the computingsystem can provide a location of the subject to the emergency serviceprovider 2428.

In some examples, the computing system can generate alerts based on atrend of the aggregated therapy data or based on therapy data that is anoutlier to the aggregate therapy data or an outlier to a time-basedaverage of the therapy data.

Further, the geolocation sensor and/or a motion sensor (e.g., anaccelerometer) can be used to detect velocity of a subject to enableintelligent motion-sensitive alerts. For example, if the subject ismoving at 60 mph and experiences low blood glucose, the system mayenable a set of driving alerts and schedule possibly therapy in thefuture. The driving alerts may inform the subject to pull overimmediately due to a risk of a hypoglycemic event. Further, an emergencyresponder may be informed of a subject location using based oninformation obtained from the geolocation sensor. If the subject ismoving at 6-7 mph, exercise alerts may be enabled to, for example, alertthe user to pause exercising and attend to low blood sugar. If thesubject hasn't moved for 3 hours and has low blood sugar, the system canenable automatic notification to emergency services. Further, adetermination of the subject's motion can be used to automaticallyadjust setpoint (e.g., raise setpoint during exercise). The activitylevel of the subject can be sensed and use to improve alerts andtherapy.

Additionally, the cloud server can send a text message or call to afollower's and/or end user's phone or smart device in case the therapydata satisfies an alert threshold. These messages may be provided fromthe cloud computing system to a third-party device in case roaming ordisabling of the data plan on the ambulatory medical device occurs(e.g., no TCP/IP available). Further, the cloud computing service maysend a text message or call 911 in case of a detected emergency. Thecloud server can track, for example, via GPS, the end user's most recentlocation and share that information with a follower and/or emergencypersonnel. Moreover, the cloud computing system may enable an end userto order and reorder medical supplies directly from the viewing device.

Moreover, the computing system can generate notifications (e.g.,generate a message when there is a risk of hypoglycemia). Further, moredetailed processing in the cloud can result in improved recommendations(e.g., Tmax, setpoint, or other control parameters)

FIG. 25 is a flow diagram illustrating an example method that may beused by computing system 2406, to generate and send alerts (e.g., alertmessages, alert signals and the like) to one or more authorized devicesand to the AMD. The method may include establishing a direct end-to-enddata connection 2502 to an ambulatory medical device, for example, via awireless wide area network (WAN) using a Narrowband Long-Term Evolution(NB-LTE) transceiver included in the AMD 2402. In some examples, thedirect end-to-end connection may be established for a given period oftime set by the subject or an authorized user (e.g., a guardian of thesubject). Once a direct end-to-end data connection between the AMD 2402and the computing system 2406 is established, the computing system mayreceive a public key 2504, from the AMD 2402 over the establishedconnection. Next, the computing system may receive a request from theAMD 2506 to transfer data (e.g., therapy data, medical sensor data orenvironmental sensor data) generated by the AMD 2402 to the computingsystem 2406 over the direct end-to-end data connection. In some cases,the request may include a time period during which AMD continuouslytransmits any data generated by the AMD 2402 or obtained from one ormore sensors (e.g., environmental sensors 2404 or medical sensors 2408),to the computing system 2406. In some such cases, the time period forcontinuous data transfer from the AMD 2402 to the computing system 2406,may be provided by the subject or a guardian of the subject to the AMD.In some examples, the computing system 2406 may use the device IDassociated with the AMD 2402 to determine whether the AMD 2402 isauthorized to transfer data 2508 to the computing system 2406. If, basedon the device ID, it is determined that the AMD 2402 is authorized totransfer data to the computing system 2406, the encrypted therapy datamay be transferred 2512 to the computing system 2406. If, based on thedevice ID, it is determined that the AMD 2402 is not authorized totransfer data to the computing system, the request may be denied 2510.The computing system 2406 may decrypt the received data 2514 using aprivate key (e.g., stored in a memory of the computing system 2406) anda public key received 2502 from the AMD 2402. In some examples, thecomputing system 2406 may determine whether the received data (e.g.,therapy data, medical sensor data or the environmental sensor data),satisfies a threshold condition 2516. In some cases, the thresholdcondition may be provided to the AMD by the subject or an authorizeduser (e.g., a guardian of the subject). In some other examples, thethreshold condition may be provided by a healthcare provider. In somesuch examples, the threshold condition may be stored in a memory of theAMD. If it is determined that the data satisfies a threshold condition,an alert may be generated and sent 2518 to one or more display systems2418 that are authorized (e.g., by the subject or a guardian of thesubject) to receive alerts. In some examples, the subject or theguardian may authorize one or more display systems 2418 to receivealerts by providing the account IDs of the one or more displays systemsto the computing system 2406 or the networked computing environment2414.

Preventing Inadvertent Therapy Changes

As described above, the ambulatory medicament device may include a userinterface (e.g., touchscreen interface or a non-touchscreen interface)that may present one or more user-interface screens to a user enablingthe user to modify one or more therapy settings of the ambulatorymedicament device, such as a quantity of medicament delivered when acondition is met or the condition that triggers the delivery ofmedicament to a subject. The user may be a subject receiving medicamentor therapy, or may be another user, such as a clinician or healthcareprovider, or a parent or guardian. For ambulatory medicament devicesthat include a user interface, there is a risk that a setting isaccidentally modified or is modified (intentionally or unintentionally)by a user that does not fully comprehend his or her action (e.g., achild or a user with a reduced mental capacity). Further, ambulatorymedicament devices may accidentally have settings modified byinadvertent interactions with a user interface, such as may occur whenan ambulatory medicament device is worn against the body of a subject.

This section relates to an ambulatory medicament device (AMD) to preventan inadvertent modification in medicament deliver, for example, in theevent of a setting of the AMD being accidentally modified by a user orinadvertent interactions with a user interface.

As mention above, in some embodiments the user may modify the control orconfiguration the AMD using a user interface. There is a possibilitythat the control or configuration of the AMD is accidentally modifiedthrough the user interface. For example, as the user may transport theambulatory medical device, there is a danger that the user willinadvertently activate input in the ambulatory medical device thatinitiates a therapy change input (e.g., by applying pressure on theambulatory medical device that may be placed in the jacket pocket of theuser).

With reference to FIG. 26, in some such embodiments, the control andcomputing module (CCM) of the AMD may include a set of therapy changeprocedures 2618 implemented to prevent therapy change inputs 2620 thatare inadvertent. The therapy change procedures 2618 may be implementedas instructions stored in a memory of CCM and executed by the processor.The therapy change input 2620, received from a user 2616, may beverified by the therapy change procedures 2618 before the ambulatorymedical device provides the therapy change delivery 2604. All the userinteractions with the user interface module 2606 may be controlled andanalyzed by the control and computing module (CCM) via one or moretherapy change procedures 2618.

In these embodiments, the user 2616 may wake or unlock the AMD byinteracting with a wake interface 2610. The wake interface 2610 can beany of the additional user interfaces mentioned above, configured togenerate a wake input to the CCM when detecting a pre-set userinteraction.

The therapy change input 2620 can be an input provided by the user 2616to change a therapy that is currently being delivered to the user 2616.In some embodiments, the therapy change input 2620 may cause the insulinor glucagon infusion pump to start infusing an amount of insulin orglucagon into the user 2616. Alternatively, the therapy change input2620 may modify the rate of insulin or glucagon infusion into the user2616. The therapy change input 2620 may also cancel insulin or glucagoninfusion into the user 2616 from the insulin or glucagon infusion pump.

When a wake action is detected by the wake interface 2610, a wake inputis sent to the control and computing module wherein it imitates a wakecontrol procedure 2626 that generates a wake signal to wake/unlock theuser interface (e.g., a touch screen display).

When in the wake and/or unlocked state, a user may interact with thetouchscreen display 2612, alphanumeric pad 2614 or other types of userinterfaces that may be included in the user interface module 2606, toobtain access to therapy change user interface.

The therapy change user interface may be activated by a first userinteraction with the user interface (e.g., touchscreen display 2612).When the first user interaction is detected, the user interface moduleuser interface module 2606 sends an input signal to the control andcomputing module wherein it is analyzed by a therapy change controlprocedure 2628. If it is determined that the first user interactionsatisfies a set of predefined conditions, the therapy change controlprocedure 2628 generates a signal to the user interface module userinterface module 2606 to activate the therapy change user interface.

In some embodiments, the therapy change user interface may be limitedbased on the first user interaction. For example, the therapy changecontrol procedure 2628 may send one of two signals to the user interfacemodule user interface module 2606. The therapy change user interface maythen unlock one of two different therapy change user interfaces thatresult in different options of therapy change selections for the user2616. In an implementation of this example, a therapy change selectionto make a significant therapy change, such as dramatically increase therate of insulin or glucagon infusion rate, requires a first userinteraction that is different from the first user interaction that wouldbe required for an insulin or glucagon infusion at a normal orprescribed rate. In some examples, the first user interaction may be asimple interaction (e.g., a simple gesture) that unlocks a therapychange user interface with therapy change selections that are limited.Another first user interaction may be a complicated interaction (e.g., aseries of complex gestures) that unlocks a therapy change user interfacewith therapy change selections that have no limits. An example of thisimplementation may be useful for child users. The child user may performthe first gesture that is made up of a series of simple inputs to unlocktherapy change selections that are limited. An adult user may performthe first gesture that is made up of a series of complex inputs tounlock the therapy change user interface with therapy change selectionsthat have no limits.

Once activated, the therapy change user interface that may provide oneor more control or configuration elements that enable the user to modifythe control or configuration of the ambulatory medicament device. Thecontrol or configuration element may include any type of user interfacescreen on the touchscreen, or other type of user interface in thenon-touchscreen context, that enables or permits a user to change aconfiguration of the ambulatory medicament device. This change inconfiguration of the ambulatory medicament device may relate to a changein the therapy provided or in the detection of a triggering event thatcauses therapy (e.g., medicament) to be provided to a subject. Forexample, the change in configuration may include a selection between oneor more hormones that regulate blood sugar level (e.g., insulin orglucagon) of a user, an amount of the one or more hormones that regulateblood sugar level of the user.

In some cases, a change to the configuration of the ambulatorymedicament device is automatically and/or instantly recognized orimplemented by the ambulatory medicament device, and/or transmitted tothe ambulatory medicament device. In other cases, a confirmation of thechange may be required before the change is implemented by ortransmitted to the ambulatory medicament device.

This confirmation may be entered based on a second user interaction witha user interface (e.g., touchscreen display 2612). When the second userinteraction is detected, the user interface module user interface module2606 sends an input signal to the control and computing module whereinit is analyzed by a therapy change control procedure 2628. If it isdetermined that the second user interaction satisfies a set ofpredefined conditions, the therapy change control procedure 2628implements the change to the configuration of the AMD.

The first and/or second user interactions may include the selection ofan icon, a series of taps or inputs, one or more gestures (e.g., alinear swipe, an arcuate swipe, a circular swipe, or other simple orcomplex movement across the touchscreen), performing a pattern orsequence on the touchscreen (e.g., drawing an image), a multi-touch ormulti-input interaction, a combination of the foregoing, or any othertype of interaction with a touchscreen, or portion thereof. The seriesof inputs may be any combination of touch movements, touch points,numerical characters, alphabetical characters, and other symbols.Gesture interactions can be guided by visual indicia displayed orprinted on the AMD. In some embodiments, the visual indicia can includeanimations that suggest or guide user interactions with a touchscreen.For example, the first user interaction can include an arcuate swipearound at least a portion of a generally circular icon or logo. In someexamples, the first and/or second user interactions may include apredetermined sequence of numerical or alphabetical inputs. In someexamples, a series of multiple inputs, the range of parameters for aninput may be dependent on other inputs in the series. For example,required start position of a touch movement may be dependent on theposition of the previous touch movement. The time that the series ofinputs are entered may also be a part of the range of parameters. Forexample, a series of inputs may need to be entered in no less than 3seconds or more than 3 seconds, and no more than 15 seconds or less than15 seconds.

Further, one or more of the interactions may include interacting with asensor as an optical sensor (e.g., visible light or IR sensor),biometric sensor (e.g., a fingerprint or retinal scanner), a proximitysensor, a gyroscope, or a combination of accelerometer and gyroscope,and the like. Also, in an exemplary embodiment, the second userinteraction may be made through a wireless signal such as RFID orBluetooth. In some embodiments, the second user interaction may includereceiving a selection of an indicator box that correspond to eitherinsulin or glucagon and receiving a predetermined sequence of numericalinputs in order to deliver the therapy change selection.

The type of user interaction that unlocks the touchscreen, providesaccess to a configuration screen, and/or confirms a change to theconfiguration of the ambulatory medicament device may be the same or maydiffer.

In an exemplary embodiment, the system may have a time-out such that ifno interaction occurs for a set period of time, the user interface willturn off and the therapy change request process has to start again. Inone implementation of the time-out, if no interaction occurs for morethan 30 seconds after the system is waked/unlocked before the seconduser interaction is received by the user interface, the user interfacewill be deactivated.

Once the configuration change is confirmed, implemented, or transmitted,the ambulatory medicament device may begin operating with the changedconfiguration.

This operation may include triggering therapy based on the newconfiguration or providing therapy based on the new configuration. Forexample, the ambulatory medicament device may generate a dose controlsignal based at least in part on the modified configuration or controlparameter, or may detect a trigger based at least in part on themodified configuration or control parameter that leads to theprovisioning of therapy.

With reference to FIG. 26, in some embodiments, the changes made throughthe therapy change user interface are sent to CCM wherein the therapychange control procedure 2628 in CCM transfers the changes to the deviceand subject monitoring procedure 2624. The device and subject monitoringprocedure 2624 may be implemented in the CCM to monitor the status ofthe AMD (e.g., therapy delivery configuration) and the health conditionof the user 2616 (or a subject). For example, the subject monitoringprocedure 2624 may receive information about a therapy change requestedby a user 2616 through a user interface (a touchscreen display 2612 oralphanumeric pad 2614) or information about glucose level in subject'sblood from the subject sensor 2608. Subsequently, the device and subjectmonitoring procedure 2624 may transmit the information pertaining ahealth condition of the subject and/or the AMD configuration, to themedicament dose control procedure 2622. In some examples, the parametersin the medicament dose control procedure 2622 may be adjusted based onthe changes and/or information captured by the device and subjectmonitoring procedure 2624. The medicament dose control procedure 2622,controls the medicament delivery interface 2602 by providing amedicament dose signal. The medicament does control may be generatedbased on detected conditions or physiological characteristics of thesubject (e.g., provided by the readings of the subject sensor 2608) andaccording to parameter values received from the therapy change controlprocedure 2628. The medicament delivery interface 2602 may provide atherapy change delivery to the user according to the informationreceived by device and subject monitoring procedure 2624.

In some examples, the dose control signals may be produced based on time(e.g., medicament may be delivered on a periodic basis), one or more acommand, indication that the subject is planning to engage or isengaging in a particular activity (e.g., eating a meal, exercising,sleeping, fasting, etc.), or any other factor that may relate to orcause the triggering of therapy (e.g., medicament delivery).

FIG. 27 is a flow diagram illustrating an example method that may beused by an AMD to allow a user to change the configuration of theambulatory medicament device using a touch screen user interface. Theuser may initiate the configuration change process by waking/unlockingthe touch screen using a wake action. Once the wake action is receivedby the wake interface 2702, the wake interface sends a wake input to CCM2704. Within CCM, the wake procedure generates a wake signal 2706 thatunlocks the touch screen 2708. Next, in response to receiving a firstgesture by the user 2710, the therapy change user interface is unlocked2712. Using one or more therapy control or configuration elementsprovided in the therapy change user interface, the user may change thetherapy configuration 2714. The user may confirm the changes made, byproviding a second gesture on the touch screen 2716. Once theconfirmation is received 2716 the requested changes will be implemented2718, and the ambulatory medicament device may begin operating with thechanged configuration. In some examples, once the user confirms thechanges made, a dose control signal may be sent to the medicamentdelivery interface 2602 that triggers a therapy change delivery to thesubject.

In some cases, the ambulatory medicament device, or a control devicethat enables a user to modify a configuration of the ambulatorymedicament device, may have a timeout feature. The timeout feature maycause the ambulatory medicament device or the control device to enter asleep or locked state after a period of time of inactivity by the user.In some cases, the timeout feature may cause the ambulatory medicamentdevice or the control device to enter a sleep or locked state after aparticular period of time regardless of whether the user is interactingwith the ambulatory medicament device or control device. Thus, a usermay have a limited period of time to modify the configuration of theambulatory medicament device.

In some examples, the therapy change made by a user may trigger thedelivery of a medicament according to the therapy change received andconfirmed by a user. This therapy change delivery may occur after a settime from period from receiving the confirmation.

In some embodiments of the AMD, an alarm status indicator may bepresented to the user via the user interface. The alarm statusindicator, can be an alert message or an alert symbol. The alarm statusindicator may be related to a configuration change made by a user, achange in the status of the AMD not related to a user input, or thecondition of the subject (e.g., detected by the subject sensor).

FIG. 28A is an illustration of the touchscreen display 2800 of anexample AMD after the touch screen is waked/unlocked by a wake action ofa user and before the first user gesture is received. Even while thetouchscreen display is locked, the touchscreen display 2800 may displayany images, animations, text, or other graphics. The first gestureprompt 2806 displays to the user 2616 the input required to unlock thetherapy change user interface. Here, the first gesture prompt 2806 showsthe user 2616 that a touch movement that begins at the greater-thansymbol and moves right across the “Unlock” text is the acceptable firstgesture. In addition to the first gesture prompt, the refill status ofthe AMD is shown in a graphic representation 2810. Here, the graphicrepresentation 2810 shows that the insulin cartridge in the AMD isalmost full. A current blood sugar level 2816 is shown at the top of thetouchscreen display 2800, which can inform the user 2616 of the need fora hormone that regulates blood sugar levels. The touchscreen display2800 also shows a graphic representation of a cartridge of glucagon2824. The graphic representation of an alarm 2830 in the touchscreendisplay 2800 shows that an alert is set on the AMD.

FIG. 28B is an illustration of an example touchscreen display 2838 thatmay prompt the user to enter a predetermined series of inputs for thefirst gesture or second gesture. In various embodiments, such as theembodiment shown in FIG. 28B, the touchscreen display 2838 may displaytouchable number keys 2840. In various embodiments, the touchscreendisplay 2838 prompts the user 2616 to enter the series of inputs thatcomplete the first gesture or second gesture. The text Enter Code 2842prompts the user 2616 to enter a predetermined or preselected numericalsequence as part of the first gesture or second gesture. The numericalsequence being typed by the user 2616 is displayed in field 2844 as itis entered as an aid to the user 2616. The input 2846 of the touchscreendisplay 2838 shows that a touch movement of a swipe right across thebottom of the screen is required to complete the predetermined series ofinputs for the first gesture or second gesture. A Bluetooth connectionsymbol 2848 shows that the ambulatory medical device 1600 is paired orcan be paired to another electronic device.

FIG. 28C is an illustration of an example therapy change user interface(in this case a touchscreen display 2802). The touch screen display maythe user 2616 prompt to select a hormone that regulates blood sugarlevel. The touchscreen display 2802 presents the user 2616 with anoption to select between two hormones. The touchscreen display 2802 aidsthe user 2616 by showing the selected hormone 2808 for the user 2616.The selected hormone 2808 is “insulin Only”. The user 2616 is also giventhe options of selecting the hormone Glucagon Only button 2812 or bothInsulin & Glucagon button 2804 to regulate blood sugar level. Once theuser 2616 selects between the one or more hormones that regulate bloodsugar level. The Next button 2814 may be selected to complete thetherapy change selection or select more options. In one embodiment, toselect more options, the therapy change user interface prompts the user2616 to select an amount of the one or more hormones that regulate bloodsugar level of the user 2616. In other embodiments, the user 2616 may beprompted to select a blood sugar level and the ambulatory medical device200 may choose the hormone and the amount of the hormone.

FIG. 28D is an illustration of another therapy change user interface ona touchscreen display 2818. Here, the user 2616 is given a multitude ofoptions. One or more options in the therapy change user interface allowthe user 2616 to make a therapy change selection. Other options arerelated to the therapy change selection. A Deliver Hormone button 2836allows the user 2616 to select a therapy change that delivers a hormonethat regulates blood sugar to the user 2616. A Test Blood Sugar button2820 allows the user 2616 to test the blood sugar level of the user2616. A Generate Report button 2822 generates a document that reportsthe therapy changes that have been delivered to the user 2616. A RefillCartridge button 2826 allows the user 2616 to fill a cartridge in theambulatory medical device 1600 with medicament. An Upload to Cloudbutton 2832 allows the user 2616 to transmit therapy change informationto a cloud-based server. A Sound Control button 2828 allows the user2616 to control the sounds emitted by the ambulatory medical device1600. A Settings button 2834 allows the user 2616 to manipulate othersettings of the ambulatory medical device 1600.

As mentioned above, in some embodiments of the AMD, an alarm statusindicator may be presented to the user via the user interface to alertthe user about a change made or occurred in the AMD configuration.

For example, with reference to FIG. 26, the user 2616 may make a therapychange input 2620 using the user interface and based on the procedureillustrated in FIG. 27. Once therapy change control procedure 2628implements the therapy change, the AMD may alert the user that a therapychange is implemented. The alert message or symbol may be presented on auser interface (e.g., touch screen display) before and/or during thetherapy change delivery 2604. For example, alarm indicator may informthe user 2616 that a therapy change is about to occur. Any number ofdetails of the therapy change may be displayed as part of the alertmessage or symbol. In some cases the alarm status indicator may appearafter the user unlocks or wakes the user interface using a wake action.

FIG. 29 is a flow diagram illustrating an example method that may beused by an AMD to generate an alarm status indicator. In someembodiments the device and subject monitoring procedure (excused withinCCM), may continuously monitor the status of the AMD (e.g., the userinterface, different modules of the AMD and the like) as well as thehealth condition of a subject (e.g., using various subject sensors suchas analyte sensors) 2902. Once a status information is received 2904,the device and subject monitoring procedure may determine whether thereceived status information satisfies an alarm condition 2906. If thereceived status information does not satisfy an alarm condition, nocation will be taken and device and subject monitoring procedurecontinuous monitoring the AMD and the subject. If it is determined thatthe received status information satisfies an alarm condition, the systemsearch for a wake signal 2908. If no wake signal is detected, thesystems waits for a wake signal to be received 2910. Once a wake signalis received via one or more user interfaces or sensors, the CCM maygenerate a display of a touchscreen lock screen interface 2912 anddisplay one or more alarm status indicators 2914, corresponding to thedetected alarm condition, on the lock screen.

In some embodiments, the AMD may allow the user to provide a therapychange and then cancel the therapy change. FIG. 30 is a flow diagramillustrating an example method that may be used to cancel a therapychange using a touchscreen interface. The user may unlock thetouchscreen display 3002 using a wake action and get access to a therapychange user interface 3004 (e.g., using a first gesture), where one ormore therapy control elements may be displayed. Next, an indication of amodification to a therapy control element may be received 3006 by theuser interface followed by a confirmation of the modification made 3008(e.g., a second gesture). In response to receiving an indication andconfirmation of a modification to a therapy control element, thecorresponding control parameter may be changes from a first setting to asecond setting 3010. In some examples, once the change is implemented3010, the user may decide to cancel it, for example, after realizingthat requested change is erroneous. In these examples the user mayprovide a third gesture 3012 on the touch screen. In response toreceiving the third gesture from the user interface the therapy changeprocedure may restore the modified control parameter to the firstsetting 3014. In some examples the third gesture may a restore gesture.In some cases, the restore gesture may be a swipe gesture. In someexamples the swipe gesture may be performed near or in a region of thetherapy change user interface that is occupied by the therapy controlelement. An example of a restore swipe gesture may be performed from astarting swipe position to an ending swipe position located closer to aleft edge of the touchscreen than the starting swipe position. In someembodiments, the restore gesture is received on a different userinterface screen than a therapy change user interface wherein one ormore therapy control element are provided. In various examples, therestore gesture is performed in the opposite direction from a therapychange confirmation gesture that confirms the modification to thetherapy control element.

In some examples, in order to cancel a therapy change request, therestore gesture has to be provided within a set time period after theconfirmation gesture is received by the user interface. In some suchexamples, during the set time period one or more dose control signalsmay be provided to the medicament delivery interface resulting in one ormore therapy change deliveries.

In some cases, the system may allow the user, to modify a therapy changebefore confirmation. In these cases, the user may modify a therapycontrol element for a second time to change the corresponding controlparameter from a second setting to a third setting.

In some examples, the third setting may be the same as the firstsetting. In some cases the first setting or the third setting may be adefault setting. In some other cases, the first setting or the thirdsetting may be a restore setting.

FIG. 31A is an illustration of a touchscreen display 3100 alerting theuser that the delivery of one or more medicaments will occur. The alertmay be accompanied by sound or vibration effects. Here, the alertinforms the user 2616 a delivery of medicament will occur in 2 seconds3102. The touchscreen display 3100 is further allowing the user 2616 toperform a gesture to cancel the therapy change. The gesture to cancelthe delivery is a touch movement that starts at the less-than symbol3104 and swipes left across the “Cancel” text. In the embodiment shownin FIG. 31A, a single gesture by the user 2616 may cancel the therapychange. In an exemplary embodiment, input of the wake signal, the firstgesture, the therapy change selection, and the second gesture are allrequired to cancel a therapy that is being delivered.

In some examples, the user may be able to cancel a therapy changedelivery triggered based on therapy change made by the user. In theseexamples, the user may get access to the user interface using a wakeaction and provide a gesture to cancel the ongoing therapy correspondingto a therapy change delivery.

FIG. 31B is an illustration of a touchscreen display 3106 showing that amedicament is being delivered to the user 2616. The text Delivering 3108informs the user 2616 that a medicament is currently being delivered tothe user 2616. The progress bar 3110 is a graphic representation of theprogress of the delivery. As shown in FIG. 31B, the delivery is onlystarting and zero progress has been completed. The touchscreen display3106 is allowing the user 2616 to perform a gesture to cancel thedelivery, which includes interrupting and discontinuing the delivery ifit had already begun but has not yet been completed. The gesture tocancel the delivery is a touch movement that starts at the less-thansymbol 3112 and swipes left across the “Cancel” text. In an exemplaryembodiment that is shown in FIG. 31B, the therapy change delivery 2604may be canceled by an input by the user 2616. The input to cancel atherapy change delivery 2604 may be any input such as a wake signalinput or a series of touch inputs such as a gesture.

Additional embodiments relating to interacting with an ambulatorymedicament device that can be combined with one or more embodiments ofthe present disclosure are described in U.S. Provisional Application No.62/874,950, which was filed on Jul. 16, 2019 and is titled “PREVENTINGINADVERTENT THERAPY CHANGES ON AN AMBULATORY MEDICAL DEVICE,” thedisclosure of which is hereby incorporated by reference in its entiretyherein for all purposes, and in U.S. Provisional Application No.62/874,954, which was filed on Jul. 16, 2019 and is titled “CAPACITIVETOUCH WAKE BUTTON FOR AN AMBULATORY MEDICAL DEVICE,” the disclosure ofwhich is hereby incorporated by reference in its entirety herein for allpurposes.

Automatic Resumption of Medicament Delivery Following Manual Suspension

In some cases, it may be desirable to suspend operation of theambulatory medicament device or to suspend at least the delivery ofmedicament by the ambulatory medicament device for a period of time. Forexample, it may be desirable to suspend an operation associated with thedelivery of medicament when the medicament reservoir or cartridge in theambulatory medicament device is empty or needs replacing. As anotherexample, it may be desirable to suspend delivery of medicament when theambulatory medicament device is removed or is being moved to anothersite on the subject. In yet another example, it may be desirable tosuspend delivery of the medicament when the subject is taking oringesting another medicament that may produce a contraindication withthe medicament provided by the ambulatory medicament device. In somecases, when a subject suspends the treatment delivered by a medicaldevice, the subject may forget to resume the treatment delivered by themedical device. In other cases, the health condition of the subject maydeteriorate during the suspension period requiring therapy deliveryprior to end of the suspension period. As such, there is a need for AMDsthat allows subjects to safely suspend treatment for temporary amountsof time.

In some embodiments, the AMD may support a therapy suspension andresumption procedure allowing a user to suspend all therapies or asubset of therapies for a period of time defined by the user as well asautomatic resumption of one or more therapies at the end of therequested suspension period or when a threshold condition is met (e.g.,a threshold condition associated with the health condition of thesubject).

In AMDs that support therapy suspension, inadvertent activation and/orresumption of therapy delivery can be dangerous (e.g., when the AMD isan insulin and/or glucagon infusion device). In some examples tomitigate this risk, the AMD may be configured to avoid inadvertentsuspension or resumption of therapies. For example, inadvertentactivations of suspensions of medicament delivery may be prevented byrequiring a user to perform gestures to activate suspension on theambulatory medical device. The gestures must be entered at a particularprompt to activate a therapy suspension.

One particular application of the therapy suspension with automaticresumption feature in an AMD can be in the field of diabetes drugdelivery. For example, the may need the ability to suspend delivery ofinsulin during situations such as exercise, which has a blood glucoselowering effect. Suspension of insulin delivery can prevent a subjectfrom entering a hypoglycemic state (extreme low blood glucose), whichcarries severe complications. Once the therapy is suspended the usermany at the risk of entering a hyperglycemic state (high blood glucosethat may result in complications such as diabetic ketoacidosis orneurovascular complications), if the user forgets to reactivate the drugdelivery after exercise. Further, the subject's blood glucose level mayraise above or below a dangerous level during the period of exercise. Inthese situations, the automatic medicament delivery resumption mayimprove the health of the subject.

In certain cases, the AMD may suspend one or more therapy deliverieswhen the AMD receives an indication that therapy (e.g., delivery ofmedicament) is to be suspended. The indication that therapy is to besuspended may be a command from a user. Often the user is the subject,but the user may also include other users that may have a say orinterest in the care of the subject. For example, the user may be aclinician or other healthcare provider, or a parent or guardian.

In some examples, the indication that the therapy or medicament deliveryis to be suspended may be a command received via an interface of theambulatory medicament device or from another device that provides theuser with an interface to request that medicament delivery be suspended.For example, the device may be a smartwatch, smartphone, laptop ordesktop, or other control device that can communicate via a wired orwireless connection with the ambulatory medical device.

In some cases, the indication that the therapy or medicament delivery isto be suspended may be received from the ambulatory medicament deviceitself. For example, if the quantity of medicament available to theambulatory medicament device drops below a threshold (e.g., thecartridge or reservoir is empty or below a minimum dosage amount), asignal may be generated to suspend medicament delivery. In someembodiments, suspension of therapy occurs based on a loss of a sensorsignal, such as the loss of a glucose level signal.

FIG. 32 illustrates the interconnection among modules and proceduresinvolved in receiving, accepting and/or canceling a therapy suspensionrequest, in an example AMD. In some embodiments, a request forsuspending one or more therapies (e.g., delivery of one or moremedicament to the subject) can be made by a user 3214 by providing auser input 3218 (e.g., the start and stop time for therapy suspension,selecting the type of therapy that should be suspended, and the like),through a therapy suspension user interface provided by the userinterface module 3204. The therapy suspension user interface sends thesuspension request along with the corresponding information to CCMwherein the therapy suspension control procedure 3226 implemented inCCM, processes and sends a therapy suspension signal to the device andsubject monitoring procedure 3222. To prevent therapy suspension requestuser inputs 3218 that are inadvertent, the therapy suspension controlprocedure may include a therapy suspension request verificationprocedure to verify the therapy suspension request.

The device and subject monitoring procedure 3222 may be implemented inthe control and computing module 3216 to monitor the status of the AMD(e.g., therapy delivery configuration) and the health condition of theuser 3214 (or a subject). For example, when the device and subjectmonitoring procedure 3222 receives the request for therapy suspension,it may send a signal to the medicament dose control procedure 3220indicating that no does control signal should be send to the medicamentdelivery interface 3202 during the period request by the user 3214. Insome cases, if during the suspension period, certain pre-set conditionsare satisfied, the device and subject monitoring procedure 3222automatically resumes the therapy delivery by sending a signal to themedicament dose control procedure 3220. For example, if during thesuspension period the subject sensor 3206 detects an elevation of thelevel of one or more analytes in subject's blood and/or interstitialfluid beyond a set threshold, it may resume the medicament delivery tothe user 3214 by a sending a dose control signal to the medicamentdelivery interface 3202.

In order to prevent inadvertent activation of a suspension, the user mayinitiate a therapy suspension request starting with a wake action (e.g.,received by the wake interface 3208 and processed by the wake controlprocedure 3224), that activates the user interface module 3204. Using afirst interaction with a user interface (e.g., a touchscreen display3210 or alphanumeric pad 3212) the user may unlock a therapy suspensionuser interface where the information pertaining therapy suspension isprovided. Next, the user may confirm the requested therapy suspensionusing a second interaction with the user interface. In some examples,the system may allow access to the therapy suspension user interface andaccept the suspension request, only if the first and second interactionwith the user interface are verified by the therapy suspension controlprocedure 3226.

In some examples, the therapy suspension control procedure 3226 mayreceive the request for suspension and suspension information fromanother device connected to the ambulatory medical device 1600 (e.g.,through the communication module).

The suspension information provided by the user may include a set ofparameters needed for a suspension. For example, the suspensioninformation may include the dates and/or times for starting and endingthe therapy suspension, threshold values needed to define a thresholdcondition that may trigger an early resumption of the therapy delivery,and the like. In some other examples, suspension information mayindicate that the suspension of therapy should happen at a particulartime or after a particular event (e.g., after the next dose ofmedicament is delivered or after the condition of the subject reaches aparticular state, such as the middle of a desired blood glucose range).In some examples, the threshold values may be associated with inputprovided by the subject sensor 3206 or other types of sensors that maybe used to monitor one or more parameters associated with the healthcondition of the user 3214.

The parameters for a suspension may include the start and stopconditions for a suspension. The start condition for a suspension may bea condition that, when met, activates a suspension. In some suchexamples, the start condition is met when a timer runs out. Similarly,the stop condition is a condition that, when met, ends the suspension.In one example, the stop condition is met when a timer runs out. Inanother example, the stop condition is met when a threshold is met. Athreshold may be related to a measurement taken by ambulatory medicaldevice (e.g., by a subject sensor 3206), such as a glucose concentrationof the blood of a user. The threshold may be met if the glucoseconcentration goes above, goes below, or matches a set concentration.Multiple conditions may be set by the suspension request interfacecomponent. For example, a time condition and a threshold condition maybe set simultaneously. A user may specify that a suspension will endafter a set time. However, the suspension may end sooner than the settime if the glucose concentration of the user meets a threshold.

In some cases, the request to suspend therapy may include an indefinitesuspension period. In other words, the request may not include a timeperiod specified by a user or an identity of a resumption condition. Insome other cases, the indication may include a request to temporarilysuspend delivery of therapy for a defined period of time or until afurther interaction or event occurs. Thus, the resumption condition caninclude an expiration of time or an active event (e.g., a command or adetermined condition of a subject). Further, the therapy to be suspendedmay include any type of therapy. For example, the therapy to besuspended may be the suspension of the delivery of medicament, which mayinclude insulin, counter-regulatory agent (e.g., Glucagon), or bothinsulin and a counter-regulatory agent. In some cases, the ambulatorymedicament device may be capable of and/or configured to administermultiple medicaments (e.g., both insulin and a counter-regulatoryagent). In some such cases, the request to suspend therapy may include arequest to suspend one (e.g., insulin or the counter-regulatory agent)or both of the medicaments.

The interactions with the user interface may include the selection of anicon, a series of taps or inputs, one or more gestures (e.g., a swipe orother simple or complex movement across the touchscreen), performing apattern or sequence on the touchscreen (e.g., drawing an image), amulti-touch or multi-input interaction, a combination of the foregoing,or any other type of interaction with a touchscreen, or portion thereof.The series of inputs may be any combination of touch movements, touchpoints, numerical characters, alphabetical characters, and othersymbols. In some examples, the first and/or second user interactions mayinclude a predetermined sequence of numerical or alphabetical inputs. Insome examples, a series of multiple inputs, the range of parameters foran input may be dependent on other inputs in the series. For example,required start position of a touch movement may be dependent on theposition of the previous touch movement. The time that the series ofinputs are entered may also be a part of the range of parameters. Forexample, a series of inputs may need to be entered in no less than 3seconds or more than 3 seconds, and no more than 15 seconds or less than15 seconds. In some cases, a visual guide may assist the user ingenerating the user interaction. For example, one or more arrows orimages may be presented to the user to guide the user in providing thecommand to suspend the delivery of therapy.

Further, one or more of the interactions may include interacting with asensor as an optical sensor (e.g., visible light or IR sensor),biometric sensor (e.g., a fingerprint or retinal scanner), a proximitysensor, a gyroscope, or a combination of accelerometer and gyroscope,and the like. Also, in an exemplary embodiment, the second userinteraction may be made through a wireless signal such as RFID orBluetooth. In some embodiments, the second user interaction may includereceiving a selection of an indicator box that correspond to eitherinsulin or glucagon and receiving a predetermined sequence of numericalinputs in order to deliver the therapy change selection.

The type of user interaction that unlocks the touchscreen, providesaccess to a therapy suspension user interface or confirms a suspensionrequest may be the same or may differ.

In an exemplary embodiment, the system may have a time-out such that ifno interaction occurs for a set period of time at each step during thetherapy suspension request process, the user interface will turn off andthe therapy suspension request process has to start again. In oneimplementation of the time-out, if no interaction occurs for more than30 seconds after the system is waked/unlocked before the second userinteraction is received by the user interface, the user interface willbe deactivated.

FIG. 33 is a flow diagram illustrating an example method for receivingand implementing a suspension request, which may be implemented by anAMD. In this example the user may use a touchscreen interface to requestand confirm a therapy suspension. Once the user activates thetouchscreen using a wake action 3302, the AMD may wait for a firstgesture on the touchscreen. After the user provides the first gestureand the gesture is verified by the therapy suspension control procedure3226, a therapy user interface may be activated 3306 where the user canrequest a therapy suspension and provide 3308 the suspension information(e.g., a start day/time and stop day/time and/or a resumptioncondition). Next, the AMD may wait for second gesture on the userinterface 3310. If the second gesture is received and verified by thetherapy suspension control procedure 3226, the therapy delivery will besuspended 3312. If the second gesture is not received or not verified bythe therapy suspension control procedure 3226, the therapy suspensioncontrol procedure 3226, may determine if a set time has passed sincereceiving the therapy suspension request 3314. If it is determined thata set time has passed since receiving the therapy suspension request,the request will be canceled and the touch screen will be locked 3316.If it is determined that time from receiving the therapy suspension isless than a set time the AMD may wait for the second gesture to bereceived.

In some examples, once a wake action is received 3302, the AMD mayautomatically activate a therapy suspension user interface 3306, withoutthe need for a first gesture 3304. In these examples, once the requestfor therapy suspension is received 3308, a gesture (e.g., a firstgesture) may be required to verify the request. In some such examples,once the therapy delivery is suspended, a second gesture may stop asuspension before any of the conditions of the stop parameter are met.This allows the user the versatility of being able to modify asuspension that has been activated.

FIG. 34 is an illustration of a plurality of screens 3400 that theambulatory medical device may display when a user activates a therapysuspension user interface. Screen 3402 shows a user interface that anambulatory medical device may display to a user 3214. The display may bea touchscreen display 3210 that can accept input that includes the firstand second gestures. The therapy suspension system of the ambulatorymedical device is not limited to the displays shown in FIG. 34. Variousdisplays may communicate, to the user 3214, the same information shownin FIG. 34. The screen 3402 allows the user 3214 to select variousfunctions. The pause button 3412, shown on screen 3402 is a functionthat suspends the delivery of a medicament to the user 3214. When thepause button 3412 is selected, the user 3214 is treated to the pausescreen 3404. The pause screen 3404 allows the user 3214 to select aduration of the medicament suspension. The ambulatory medical device maydisplay various interfaces to allow the user 3214 to select a durationof the medicament suspension. The pause screen 3404 shows a simpleinterface, giving the user 3214 one of two duration options.

When the user 3214 has made a duration selection on the pause screen3404, the pause screen 3406 shows the user 3214 the duration 3414 thatthe user 3214 selected (e.g., in the figure the user 3214 selected 1hour. Thus the medicament delivery is suspended for 1 hour after thesuspension begins). The pause screen 3406 has a prompt 3408 for the userto make a gesture to confirm the requested suspension before themedicament suspension begins. As shown by the prompt 3408, the user 3214is being prompted to swipe right across the bottom of the screen. Oncethe user 3214 performs the gesture to begin the medicament suspension,the suspension screen 3410 is displayed on the touchscreen. Thesuspension screen 3410 informs the user 3214 that the medicament ispaused. The user 3214 has the option of performing another gesture tounlock the ambulatory medical device. The prompt 3416 for the user 3214to unlock the device forces the user to perform another swipe to executemore functions on the ambulatory medical device 1600.

Suspending the medicament delivery may occur by not generating a dosecontrol signal to deliver a dose of medicament. Alternatively, or inaddition, suspending the medicament delivery may occur by sending asignal to the medicament pump to cease providing therapy or medicamentto the subject.

In some cases, the ambulatory medicament device may not immediatelysuspend therapy upon receiving a command to suspend therapy. Forexample, if the ambulatory medicament device is in the process ofdelivering medicament or determines that a condition of the subjectindicates that medicament may soon be required to maintain the subject'scondition (e.g., blood glucose) within a particular state (e.g., withina desired blood glucose range), the suspension of therapy may be delayeduntil at least such time that medicament is not being delivered, ispredicted to not be required during the suspension period, or the nexttherapy has been delivered. In some such cases, the ambulatorymedicament device may inform that user that the suspension of therapy isbeing delayed. Further, the ambulatory medicament device may indicatethe reason for the delay. In some cases, the user may be able tooverride the delay and request immediate suspension of therapy. Forexample, if the user is replacing the medicament cartridge, the user mayoverride an indication that the suspension of therapy should be delayed.In some cases, the requested start time may be overridden by adetermined condition of the subject.

The suspension of therapy or the suspension of the delivery ofmedicament may continue until a resumption condition occurs. In certaincases, when a resumption condition is met, the suspension period mayautomatically end without action by the user or subject.

The resumption condition may include the expiration of a time period, acommand from a user (e.g., the subject), detection that the ambulatorymedicament devise satisfies a condition (e.g., that medicament has beenrefilled), that the condition of the subject meets certain criteria(e.g., the subject's blood glucose level drops below a threshold rangeor rises above a threshold range), or any other condition that maysatisfy the reason for suspension of therapy or that overrides therequest for suspension of therapy. For example, the drug delivery devicemay be configured to automatically resume drug delivery when a glucosethreshold is reached or exceeded. This threshold could be set to 300mg/dl for example. The resumption condition may include detection of animpending risk of hypoglycemia or hyperglycemia, or a hypoglycemia orhyperglycemia event. Further, the resumption condition may include ameal announcement, or an “exercise concluded announcement,” a motionsensing event, a pause of other administered medicament, a conclusion ofan undefined suspension length (e.g., during cartridge change), aspeed-based resumption event, a location-based resumption, a remoteresumption in case of an emergency (e.g., commanded from caregiver adminsoftware or clinician), or any other type of resumption event. In somecases, the resumption condition can include a combination of criteria.

In some cases, automatically resuming therapy may include discontinuingthe suspension of therapy before the expiration of the suspensionperiod. For example, if a condition that caused therapy to be suspendedis resolved prior to the expiration of the suspension period, therapymay be resumed.

In some cases, when a resumption condition (provided by the user) ismet, the ambulatory medicament device may confirm that one or moreadditional condition of the ambulatory medicament device are satisfiedbefore therapy is resumed. For example, if the ambulatory medicamentdevice determines that medicament has not been refilled or if there is aproblem with the refill (e.g., cartridge is incorrectly installed), theambulatory medicament device may continue to maintain the suspension oftherapy despite the trigger to resume therapy.

In some examples, a therapy suspension may be ended if a thirdinteraction with a user interface (e.g., a gesture) is detected. Thethird user interface interaction may be detected by the user interfacemodule 3204 and sent to the therapy suspension control procedure 3226.If the therapy suspension control procedure 3226 verifies that thirdinteraction with the user interface is a predetermined third userinterface interaction, it may send a signal to the device and subjectmonitoring procedure 3222 to activate the medicament dose controlprocedure 3220. This allows the user the versatility of being able toend a suspension that has been activated, during the suspension periodset by the user before the confirmation (second interface with the userinterface). In some cases, a user may decide to end a therapy suspensionto modify one or more suspension conditions set prior to activation ofthe current therapy suspension. In some other examples, user may decideto end a therapy suspension due to change in user's health condition notincluded in one or more therapy resumption conditions provided beforeactivating the current therapy suspension.

FIG. 35 is a flow diagram illustrating an example method of resuming asuspended therapy that may be implemented by an AMD. Once a therapysuspension has been requested and confirmed by a user (e.g., using theprocedure illustrated in FIG. 18) 3502, the AMD suspends one or moretherapies selected for suspension 3504 at suspension initiation timereceived as part of the suspension information. For example, therapysuspension control procedure 3226 deactivates the medicament dosecontrol procedure 3220 using the device and subject monitoring procedure3222. During the suspension period, the therapy suspension controlprocedure 3226 continuously monitors the system clock and the subjectand device condition (e.g., using medicament dose control procedure3220).

If the therapy suspension control procedure 3226 determines that thetime passed since the suspension initiation is less than the requestedsuspension time period 3506 and none of condition for resumption hasbeen met 3508, the therapy suspension continues.

If the therapy suspension control procedure 3226 determines that thetime passed since the suspension initiation is equal to the requestedsuspension time period 3506, or one or more resumption conditions havebeen met 3508, it may check other AMD or subject conditions (notincluded in the therapy suspension information), in order to determinewhether the therapy delivery can be safely resumed 3510. If it isdetermined that the therapy delivery cannot be safely resumed, an alertmessage will be send to the user interface to inform the about thereason for such determination 3514. If it is determined that the therapydelivery can be safely resumed, the one or more suspended therapies willbe resumed 3512.

FIG. 36 is an illustration 3600 of a plurality of screens that may bedisplayed, for example, on a touchscreen display when a user 3214resumes a suspended therapy. Screen 3602 informs the user that thedelivery of medicament is currently in a suspended mode. The screen 3612also shows the user 3214 the current glucose concentration of the bloodof the user 3214. The ambulatory medical device may display variousvital measurements that are useful to the user 3214. In oneimplementation, the medicament suspension ends if the glucoseconcentration of the blood of the user meets or passes a threshold.

The interface screen 3604 allows the user 3214 to select and executevarious functions on the ambulatory medical device. The resume button3614 is a function that ends a medicament suspension. When the resumebutton 3614 is selected, the ambulatory medical device displays a resumescreen 3606. The resume screen 3606 has a prompt 3616 that prompts theuser 3214 to perform a gesture. In the examples shown, the user 3214receives a prompt 3616 in the resume screen to swipe right across thebottom of the resume screen 3606. The requirement to perform the gestureto resume medicament delivery prevents the user 3214 from inadvertentlyresuming medicament delivery in the ambulatory medical device.

Once the user 3214 performs the gesture to resume medicament delivery,the medicament suspension ends. The resumption screen 3608 shows theuser 3214 that the regular medicament delivery has resumed. Once theresumption screen 3608 has been displayed to the user 3214 for asufficient amount of time to inform the user 3214 that the suspension isending, the ambulatory medical device may display a lock screen 3610.The lock screen 3610 prevents the user 3214 from inadvertently executingmore functions on the ambulatory medical device.

In one embodiment, the ambulatory medical device must receive a secondgesture to end the suspension before the one or more conditions to endthe suspension are met. The purpose of the second gesture is to ensurethat the user 3214 does not inadvertently end the suspension. Like thefirst gesture, the second gesture may be simple or complex.

With reference to FIG. 32, once the AMD device is instructed to resumetherapy and/or determines that therapy is to be resumed, the ambulatorymedicament device may determine whether a dose of medicament should besupplied to the user based on a control algorithm used by the ambulatorymedicament device to control the provisioning of medicament to thesubject. For example, the therapy suspension control procedure 3226 maydetermine a resumption condition has been satisfied or receive a userinput from the user interface module 3204 (a third interaction with auser interface) indicating that therapy suspension should be ended.Subsequently the therapy suspension control procedure 3226 may send asignal to the device and subject monitoring procedure 3222 to activatethe medicament dose control procedure 3220. If medicament is to besupplied, the medicament does medicament dose control procedure 3220 maygenerate and send a dose control signal to the medicament deliveryinterface 3202.

In some cases, the ambulatory medicament device may alert the userand/or the subject that therapy is being resumed. This alert may occurbefore generating a dose control signal and/or after a resumptioncondition is satisfied (e.g., a suspension time expires). In some cases,the user may request that the suspension of therapy end early. The usermay request the early resumption of therapy be interacting with theaforementioned user interface using one or more of the previouslydescribed interaction methods (e.g., gestures or taps).

Additional embodiments relating to suspending medicament delivery to asubject that can be combined with one or more embodiments of the presentdisclosure are described in U.S. Provisional Application No. 62/910,970,which was filed on Oct. 4, 2019 and is titled “METHOD FOR SU SPENDINGDELIVERY OF A DRUG INFUSION DEVICE WITH AUTOMATIC RESUMPTION OFDELIVERY,” the disclosure of which is hereby incorporated by referencein its entirety herein for all purposes.

AMD with Security Functionality

An ambulatory medicament device (AMD), such as, but not limited to, aninsulin pump, that provides life-saving treatment to subjects orsubjects based on the condition of the subject, may include a userinterface (e.g., a touchscreen display) that lets a user to modify thesettings of the ambulatory medicament device. The setting may include,but not limited to, a condition that triggers the delivery of medicamentto a subject, the quantity of medicament delivered when a condition ismet, type of the medicament and the like. The setting may also includefeatures of the AMD that may not be directly related to the medicamentdelivery (e.g., the screen brightness, an alarm sound, and the like). Insome examples, it is desirable to manage access to various settings ofAMD in order to avoid inadvertent changes while enabling changes thatmay be necessary for uninterrupted and proper operation of the AMD. Forexample, it may be desirable to limit the access to some settings tocertain authorized users (e.g., a healthcare provider) while enableaccess to some other settings other authorized users (e.g., the subject,a guardian or parent of the subject).

In many cases, a healthcare provider can modify the settings of theambulatory medicament device. However, it is often desirable that anon-healthcare provider modify at least some settings of the ambulatorymedicament device. For example, when the ambulatory medicament deviceruns out of or has below a threshold amount of medicament, it is oftendesirable that a user be able to refill or change a medicament cartridgewithout visiting a healthcare provider. In some cases, changing themedicament cartridge may include interacting with a user interfaceand/or one or more settings of the ambulatory medicament device. Anotherexample of when it is desirable for a non-healthcare user (e.g., asubject, parent, or guardian) to modify settings of the ambulatorymedicament device is when the initial settings of the ambulatorymedicament device are not providing the desired effect (e.g., sufficientmedicament, too much medicament, providing the medicament too slowly ortoo fast, etc.). In some cases, normal maintenance of the ambulatorymedicament device and/or subject may require interaction with theambulatory medicament device settings and/or controls. For example,negative consequences may being to occur when an ambulatory medicamentdevice remains connected to a subject at the same site for more than athreshold period of time (e.g., for more than 2-3 days, more than 5days, more than a week, etc.). Thus, the ambulatory medicament devicemay need to be periodically moved from one site on the subject toanother site on the subject (e.g., from left-side to right-side, fromarm to leg, from stomach to back, etc.). The change in site location mayrequire interaction with settings of the ambulatory medicament device(e.g., pausing operation until the site change is completed).

Although, as explained above, there are a number of reasons it isdesirable to enable a user other than a healthcare provider (e.g., thesubject receiving therapy, a parent, or a guardian) to have access to atleast some user settings of an ambulatory medicament device, it is alsodesirable to regulate access to at least some of the ambulatorymedicament device settings. For example, it is generally undesirablethat a child (subject or otherwise), or a user below a particular age,have access to ambulatory medicament device settings that could causeharm to the subject if modified. Further, it may be undesirable forcertain subjects who have diminished mental capacity regardless of ageto have access to at least some ambulatory medicament settings.

The user may be a subject receiving medicament or therapy, or may beanother user, such as a clinician or healthcare provider, or a parent orguardian of the subject. In some examples, the passcode required forchanging one or more setting via an intermediary device may be differentthat the passcode required for changing the same settings directly usingthe AMD's user interface.

One solution to regulating access to settings of the ambulatorymedicament device is to implement a lock feature to require that a userprovide a passcode, a passcode, or other information before the user ispermitted to modify a setting of the AMD, such as a control parameter.To simplify discussion, the disclosure will describe using a passcode.However, it should be understood that the passcode can be substitutedfor a passcode or any other type of secret or semi-secret information.In some examples, when the AMD is in the locked state, it may continuedelivering therapy to the subject at the same rate as unlocked state.

The lock feature may be activated by default, or may be activated by auser. In some examples, the lock feature can be enabled through asetting in a control menu of the AMD device provided on a user interface(i.e., touchscreen display). The setting may include an on/off toggle(e.g., a software interface element or a hardware interface element) sowhen the toggle is on, a passcode (e.g., 4 to 8 numeric digits) may berequired. In some cases, if the lock feature is on, the passcode (e.g.,a 4 to 8 numeric digit code) may be required to turn the lock featureoff. When the lock feature is activated, the user may program theambulatory medicament device with a user passcode selected by the user.Alternatively, or in addition, the user passcode may be set in responseto a passcode change request. In some cases, a user passcode may expire.In such cases, a user may be required to generate a new passcode afterthe previous passcode expires or before the previous passcode ispermitted to expire. In other cases, the ambulatory medicament devicemay periodically generate a new passcode (e.g., an override passcode),or may generate the passcode at a time when a user supplies thepasscode.

In some cases, the user interface element used for accessing a userinterface that enable changing one or more settings of the AMD maydiffer from the a user interface for modifying the control parametersassociated with that setting. For example, a keypad may be used to entera passcode for unlocking a user interface for changing a controlparameter and a touchscreen may be used to modify the control parameter.

When the lock feature is enabled, the user interface screen may look andfunction the same as if the lock feature were not enabled. If the lockfeature is enabled, when a visual guide for unlocking the device (suchas, for example, a linear unlock slider, an arcuate unlock slider, oranother unlock user interface element) is activated, a passcode entryinterface (e.g., a keypad user interface element) may be displayed. Ifeither the user passcode or the global override passcode is entered, theuser interface may proceed as normal. Otherwise, the user interface mayrevert back to the original lock screen.

In some examples, the user action that permits a user to change one ormore settings of the AMD may be different from the wake action thatactivates a user interface. For example, a wake action may be used toactivate a touchscreen display that may display a plurality of userselectable elements some of which may be accessible without a passcode.In such examples, a subset of the user selectable elements, for examplethose allowing the user to change therapy control parameters, mayrequire a passcode. In some cases, access to each user parameter controlelement may require a different passcode. In some other examples,providing a passcode may to an AMD in locked state, may directly enableaccess to a subset of control parameter elements.

To help recall the passcode, the passcode may be set by the userenabling the user to select a passcode the user is more likely toremember. However, regardless of who sets the passcode, there is a riskthat the user will not remember the passcode. Due to the nature of thedevice (e.g., a device that may provide life-saving treatment), it isdesirable that certain user's not be restricted from accessingparticular settings of the ambulatory medicament device, and be able toquickly (e.g., within seconds, minutes, prior to a next therapy event,or before harm may occur to the subject) obtain access to the particularsettings when required. Thus, while some non-medical devices mayimplement lockout periods or other restrictions to prevent a malicioususer from trying to brute-force determine a passcode for a device, suchfeatures are generally undesirable for an ambulatory medicament device.Accordingly, embodiments disclosed herein include an ambulatorymedicament device that includes an override passcode that enables accessto the ambulatory medicament device (or control settings thereof)regardless of whether the user passcode is provided.

In some examples the passcode or the override passcode can be a seriesof taps, series of inputs, a complex or a simple gesture (e.g., a swipeor other movement across the touchscreen), The series of inputs may beany combination of touch movements, touch points, numerical characters,alphabetical characters, and other symbols. In some examples, the timethat the series of inputs are entered may also be a part of the range ofparameters. For example, a series of inputs may need to be entered in noless than 3 seconds or more than 3 seconds, and no more than 15 secondsor less than 15 seconds. One example of the complex gesture is a swipe.

In some other examples the passcode or the override passcode can be acomplex or a simple gesture (e.g., a swipe or other movement across thetouchscreen), performing a pattern or sequence on the touchscreen (e.g.,drawing an image), a multi-touch interaction, a combination of theforegoing, or any other type of interaction with a touchscreen, orportion thereof. Another example of a complex gesture is entering apredetermined sequence of touches. In some cases, the passcode mayinclude a quiz or set of questions,

In some examples, the ambulatory medicament device may be configured toreceive therapy settings or modifications to therapy settings from anintermediary device via a communication connection. In some cases, thisfeature may be supported in addition to providing the user with optionof modifying one or more settings with a user interface of the AMD. Thecommunication connection between the intermediary device and the AMD maybe a direct connection via, for example, Bluetooth®, or a connection viaa network, such as over a local area network or a wide area network. Insome such cases, the ambulatory medicament device may include a wirelesstransceiver, such as an NB-LTE transceiver, a Wi-Fi transceiver, or aBluetooth transceiver. The intermediary device, that provides the userwith a user interface to modify settings of the AMD, include any type ofdevice (e.g., a computing device) that can communicate with anambulatory medicament device. For example, the intermediary device maybe a laptop or desktop computer, a smartwatch, a smartphone, or ahardware control device that may be configured to interact with theambulatory medicament device. Embodiments disclosed herein areapplicable regardless of whether the user interface for modifyingtherapy settings or the configuration of the ambulatory medicamentdevice is generated or presented by the ambulatory medicament device tothe user or via another device. In some such cases, a user may provide auser-generated passcode or an override passcode via an interface of thecomputing device. The computing device may then provide theuser-generated passcode or the override passcode to the ambulatorymedicament device via the network connection between the devices.

In some examples, even if the AMD is in locked state, certainintermediary devices may have access to user interfaces that may be usedto change one or more settings (e.g., therapy settings) of the AMD. Forexample, the smart phone of a guardian or a parent of the subject may beused to change one or more settings of the AMD while the AMD is in thelocked state.

In some examples, the AMD may be configured to receive a passcode fromor via a computing systems (e.g., a cloud computing system). In theseexamples, the AMD may receive passcode through a direct end-to-endconnection (e.g., a wireless connection over a wide area network)stablished with the computing system. In some such examples, anothercomputing device (e.g., a smartphone, a laptop, a personal computer, andthe like) connected to the computing system, may send a passcode to theAMD and be able to change one or more settings of the AMD if thepasscode is validated by the AMD.

In cases where the user cannot recall the user passcode, the user canobtain access to the user interface that permits modification of thecontrol parameter by supplying an override passcode. In some examples,the override passcode may be a universal fixed passcode (e.g., an8-digit override passcode) that can be used instead of the user setpasscode. The override passcode can be stored in the ambulatorymedicament device at the time of manufacture and may be shared amongmultiple ambulatory medicament devices (e.g., a global overridepasscode), or may be unique to a particular ambulatory medicamentdevice. The override passcode may be managed by the manufacturer or by athird-party service. To obtain the override passcode, the user maycontact the manufacturer or passcode managing service. Generally,enabling the passcode may exist to prevent a user with a diminishedmental capacity (e.g., a child) from modifying settings of theambulatory medicament device. Thus, security may be less of a concernand any user can contact the manufacturer or passcode managing serviceto obtain the override passcode. In some such cases, a single globaloverride may be used for all devices produced by the manufacturer.However, in some cases, a level of security may be desired. In some suchcases, it may be necessary for the user to authenticate him or herself.Further, the user may be required to provide a serial number of theambulatory medicament device. In some cases, each model or each unit ofthe ambulatory medicament device may have a different override passcode.The user may provide authorization information and a serial number ofthe ambulatory medicament device to the manufacturer or passcodemanaging service to obtain the override passcode.

In some examples, may periodically generate a new override passcode ormay generate an override passcode at a time when a user supplies thepasscode. In these examples, the ambulatory medicament device may usethe same parametric values to generate the override passcode as anotherdevice may use thereby ensuring a match between the override passcodes.Advantageously, in some cases, by using an algorithm to generate theoverride passcode, the override passcode can be obtained regardless ofwhether a user is able to contact a manufacturer or other passcodemanaging service. In some cases, the user may generate the overridepasscode without access to a network or phone using, for example, acomputing device that can access a common parameter value as theambulatory medicament device.

In some cases, the override passcode may change over time or be arotating passcode. For example, in some cases, the override passcode maychange every thirty seconds, every minute, every hour, etc. In some suchcases, the override passcode may be determined from an algorithmexecuted by an application. The ambulatory medicament device may store acopy of the algorithm in a memory of the ambulatory medicament deviceand may execute the algorithm to determine the override passcode that iscurrently valid. A copy of the algorithm may be executed by anothercomputing device accessible by the user. The output of the algorithm maybe based on a value that is commonly accessible by the ambulatorymedicament device and the copy of the algorithm accessible by thecomputing device. For example, the output of the algorithm may begenerated based on a time, a user identifier, a provided value, or anyother factor that may be used to repeatedly generate the same output. Insome cases, the override passcode may be calculated based on acombination of factors. For example, the override passcode may becalculated based on a portion of a serial number or model number for theambulatory medicament device and the time. The determination of theoverride passcode may be calculated by the ambulatory medicament device,a computer server, and/or an application on a user device.

In some cases, the override code can be automatically received by theambulatory medicament device. Thus, a user may not need to see or enterthe override code. In some cases, the override code may be transmittedto another device of the user (e.g., a smartphone or laptop). Forexample, the override code can be texted to a user's smartphone. In somecases, the override code may be received in a coded manner that may notbe understandable by a child or user with diminished mental capacity.

In some cases, the override passcode may be linked to a location. Forexample, the override passcode may only be enterable at a healthcareprovider's office or at the subject's place of residence. Thedetermination of the location of the ambulatory medicament device may bebased on a geolocation system (e.g., a Global positioning System (GPS))available to the ambulatory medicament device.

In some examples, at least for a subset of therapy settings, thepasscode may provide a second level of security in addition to otherinteractions with the user interface (e.g., a first and a second gestureon a touchscreen display) that may be used to change the therapysettings and/or accept the change made to a therapy setting. In someother examples, at least for a subset of settings, the passcode may beused instead of other interactions with the user interface (describedabove).

As mentioned above, interacting with the user interface may cause theambulatory medicament device, or other device that can modify a controlof the ambulatory medicament device, to present a passcode input screento the user. The user may enter the passcode to unlock additional userinterface features including, for example, a user interface that enablesthe user to modify at least one control parameter of the ambulatorymedicament device. The control parameter can be modified based on aninteraction with a parameter control element of the user interface.Further, modification of the control parameter may cause modification ofthe generation of a dose control signal that is generated by a controlalgorithm based at least in part on the control parameter.

In some embodiments, the ambulatory medicament device may have anadvanced therapy screen, or other user interface, that permits ahealthcare provider, or other user, to obtain additional detailsrelating to therapy provided by the ambulatory medicament device.Although the advanced therapy screen may generally be intended for aknowledgeable user, such as a clinician, in some cases, any user mayobtain access to the advanced therapy screen. The advanced therapyscreen may permit the healthcare provider to modify control parametersthat may not be modifiable by other users. For example, the healthcareprovider may be able to control parameters that relate to thecalculation of a rate of insulin accumulation, the rate the insulindiminishes within the blood of the subject, the setting of a glucosesetpoint, an aggression level or factor of therapy relating to an amountof insulin provided when the subject's glucose level is outside thesetpoint range, or when the insulin reaches a point of maximumconcentration within the blood of the subject (e.g., T_(max)).

Access to the advanced therapy screen may be limited by requirement of apasscode, which may be referred to as a clinician passcode todistinguish it from the user-generated passcode and/or the overridepasscode. This clinician passcode may or may not be user-generated.However, the clinician passcode may be a separate passcode from theuser-generated passcode that permits access to the non-advanced therapyscreen interface. Further, the clinician passcode may be separate fromthe override passcode that permits a user to override the user-generatedpasscode to obtain access to the non-advanced therapy screen interface.In some cases, the clinician passcode may be used as an overridepasscode. In some example the clinician passcode can be valid for periodof time (e.g., set by a subject or another authorized user such as theguardian or apparent of the subject). For example, the clinicianpasscode may be valid for a day, a week or a month. In some examples,the AMD may allow certain authorized users to terminate the clinicianaccess at any time.

In some cases, access to the advanced therapy screen may be limited to aparticular period of time. After the time period expires, the ambulatorymedicament device may automatically restrict access to the advancedtherapy screen. In some cases, the user interface of access may beextended. For example, if the healthcare provider is continuing tointeract with the advanced therapy screen, the screen may remainaccessible.

In some cases, the advanced therapy screen may provide additionalfeatures. For example, while a user may be able to indicate that anamount of insulin provided for a meal or as a correction factor shouldbe higher or lower, the healthcare provider may be able to specificallyadjust the amount of insulin. Moreover, while a user's direction may ormay not be followed depending, for example, if the request exceeds athreshold or may cause blood glucose to not satisfy a setpoint range, anindication provided via the advanced therapy screen may be followedregardless, or may have a wider range or different threshold that maycontrol whether the instruction is followed. Further, the advancedtherapy screen may be used to temporarily pause therapy and/or mayprevent subject access.

In some cases, the manufacturer of the ambulatory medicament device mayprovide a remote unlock signal that can be used to unlock access to theambulatory medicament device and/or to an advanced therapy screen of theambulatory medicament device.

As described above, the passcode may be desired to prevent particularusers from inadvertently changing certain control parameters of theambulatory medicament device. However, features of the ambulatorymedicament device that do not affect therapy may remain accessible to auser when the ambulatory medicament device is in a locked state. Forexample, a user may be able to access therapy history, screen brightnesssettings or colors, or any other feature that is unlikely to harm asubject if modified in a particular manner. Further, as the passcodefeature is generally to prevent control parameter changes, theambulatory medicament device may provide therapy and continue to providetherapy at the same rate and under the same condition, whether or notthe ambulatory medicament device is locked or unlocked.

When the ambulatory medicament device receives the user passcode or theoverride passcode, the ambulatory medicament device validates thepasscode. The passcode may be validated by comparing the receivedpasscode to a passcode stored in a memory of the ambulatory medicamentdevice or generated by the ambulatory medicament device. If the passcodereceived from the user is successfully validated, the user may begranted access to a user interface to modify one or more controlparameters. In some cases, the user may be requested to re-enter apasscode to confirm a change to a control parameter. In some otherexamples, the user may be requested to provide a gesture on atouchscreen to confirm a change to a control parameter.

If the passcode is not validated, the ambulatory medicament device, orother control device that can provide access to control parameters ofthe ambulatory medicament device, may prevent access to the userinterface to modify the one or more control parameters. In some cases,the user interface that presents the user with the ability to enter thepasscode may permit the user a particular number of tries or aparticular number of tries within a particular time period to enter theuser passcode. If the correct user passcode is not entered within theprovided number of tries or within the particular time period, the userinterface may enter a lock state (e.g., the screen will be turned off)and prevent further attempts to enter a passcode for at least a periodof time. In some cases, the user passcode option may be indefinitelylocked or blocked. In some such cases, the control parameters of theambulatory medical device may only be accessible if the overridepasscode is provided. Alternatively, or in addition, a user passcode ofa different user may be used to provide access to the control parametersof the ambulatory medical device. In some examples, if the correctoverride passcode is not entered within the provided number of tries orwithin the particular time period, the user interface may block anyattempt to change the override passcode for at least a period of time.

In some cases, once the passcode is successfully entered or validated, auser may deactivate the passcode feature of the ambulatory medicamentdevice. Deactivating the passcode feature may require use of a separatepasscode or the override passcode in addition to the user passcode.

In some cases, the passcode may be optional or omitted based on thecomputing device connected to the ambulatory medicament device. Forexample, if the end-to-end connection is established between asmartphone registered to a particular user (e.g., a parent of thesubject), the ambulatory medicament device may unlock automaticallywithout requiring a passcode. In other cases, the smartphone, or othercomputing device, may automatically provide the user-generated passcodeor the override passcode to the ambulatory medicament device uponestablishing a connection. In some cases, the ambulatory medicamentdevice may automatically be unlocked when connected to a charger or whenin a particular geographic area. For example, a geo-fence may beconfigured in one or more locations, such as the subject's house or theclinician's office. When the ambulatory medicament device determines itis within the geo-fence, the ambulatory medicament device mayautomatically be unlocked. Similarly, when the ambulatory medicamentdevice determines that it is not within the geo-fenced region, it mayautomatically be locked. The determination of the location of theambulatory medicament device may be made based on a geo-location system,such as the Global Positioning System (GPS).

In some cases, after a certain number of unsuccessful passcodes areentered (e.g., after 5 tries), the user interface screen may be turnedoff or may accept only the global override passcode

Example AMD with Security Codes

FIG. 37 is a block diagram illustrating the interconnection amongmodules and procedures in AMD involved in changing the settings of theAMD. In some cases, one or more settings of the AMD may be changed usinga setting change input 3716 to one or more parameter control elementparameter control elements 3730/3734/3738 presented on one or moresetting user interface screens 3728/3732/3736 provided by the userinterface module 3702. In some examples, when the lock feature isactivated, access to one or more setting control screens 3728/3732/3736and/or one or more parameter control element 3730/3734/3738, may beprotected by a passcode. In order to change a parameter control element3730/3734/3738, the user may provide a passcode input 3718 (e.g., a usergenerated passcode or an override passcode), via the user interfacemodule 3702 (e.g., using a touchscreen display 3706 or alphanumeric pad3708). Alternatively or in addition the user 3710 may provide a passcode3740 using an intermediary device (e.g., a laptop, a smart phone and thelike) that is connected to the AMD (e.g., via a wireless link). In someexamples, the access to one or more setting user interface screens3728/3732/3736 and/or parameter control element parameter controlelements 3730/3734/3738, may be managed by setting change procedures3712 stored in a memory in the control and computing module of the AMD.A hard processor may execute the machine readable instructionsassociated with the setting change procedures 3712.

In some examples, the option to provide a passcode may become available,when the user 3710 performs a wake action on a wake interface 3704. Inthese examples if the wake control procedure 3722 of the CCM determinesthat a valid wake action is performed, it may present selectableelements associated with the setting user interface screens3728/3732/3736, for example, on a touchscreen display. In some otherexamples, the first screen presented on the touchscreen display, mayprovide other selectable elements including an element to change thesettings of the AMD. In such examples, selecting element associated withsettings change may activate a second screen that presents selectableelements associated with the setting user interface screens3728/3732/3736. When the lock feature is activated, access to any of thesetting user interface screens 3728/3732/3736 and/or parameter controlelement 3730/3734/3738 may require a passcode. In some examples, eachone of the user interface screens 3728/3732/3736 and/or parametercontrol element 3730/3734/3738 may require a different passcode. In someother examples, one or more user interface screens 3728/3732/3736 and/orparameter control element 3730/3734/3738 may not require a passcode. Forexample, access to the first user interface screen 3728 may require afirst passcode, the access to the second user interface screen 3732 mayrequire a second passcode and the access to the third user interfacescreen 3736 may not need a passcode. In yet another examples, all theuser interface screens 3728/3732/3736 may be presented without the needfor providing a passcode, but access to the one or more control elementsin a control screen may require a passcode. For example, the user mayselect the second user interface screen 3732 without entering a passcodebut in order to select one or more parameter control element 3734 onthat screen, the user may need to enter one or more passcodes.

In some examples, once a passcode or override passcode received from theintermediary device 3714 or the user interface module 3702, the passcodemay be transmitted to the control and computing unit of the AMD wherethe setting change procedures 3712 (therapy change control procedure3720 and wake control procedure 3722) determine the validity of thepasscode by comparing it to the one or more stored user generatedpasswords 3726 or received or stored override passwords 3724 stored in amemory of the CCM.

FIG. 38 is a flow diagram illustrating an example method that may beused by an AMD to allow a user to change a setting of the AMD using auser generated passcode or an override passcode. Once the AMD (e.g., thewake action procedure in the CCM) receives a valid wake action 3802, auser interface may be activated. In some example, the wake action maydirectly activate a setting change interface 3804 (e.g., a settingchange screen presented on a touchscreen display). In some examples, aspecific wake action may activate the setting change interface. On thesetting change interface 3806, the AMD (e.g., the setting changeprocedure in the CCM) may request a passcode (e.g., by presenting a userinterface to enter a passcode). Once a passcode is received, the AMD(e.g., the setting change procedure in the CCM) may determine whetherthe passcode matches a user generated passcode 3808. If it is determinedthe passcode matches with a user generated passcode, the AMD may provideaccess 3810 to one or more control parameter elements associated withthe received passcode. If the received passcode dose not match with anyof the stored user generated passcode, the AMD may determine whether thepasscode matches with an override passcode 3812. If it is determined thepasscode matches an override passcode stored in a memory of AMD or amemory of an authorized computing device, the AMD may provide access3814 to one or more control parameter elements associated with thereceived override passcode. If it is determined the passcode does notmatches an override passcode, the AMD denies access 3816 to one or morepasscode protected control elements.

FIG. 39 is a flow diagram illustrating another example method that maybe used by an AMD to allow a user to change a setting of the AMD using auser generated passcode or an override passcode. Once the AMD (e.g., thewake action procedure in the CCM) receives a valid wake action 3902, theAMD may provide a user interface (e.g., a touchscreen display) on whichthe user can provide a first gesture to activate a setting changeinterface or screen. When a first gesture is received from a user orsubject 3904, the AMD may activate a setting change interface 3906 or ascreen. In some examples, the setting change interface or a screen mayinclude one or more parameter control elements associated with one ormore settings of the AMD. In some other examples, the setting changeinterface or a screen may include one or more selectable elements eachassociated with a setting change screen (e.g., a screen provided on atouchscreen display) that may include one or more control parameters.When a request for setting change is received 3908, the AMD maydetermine whether the requested setting change is passcode protected ornot 3910. In some examples, the request for setting change may includeselecting a parameter control element. In some other examples, therequest for setting change may include selecting a list of parametercontrol elements (e.g., included in a separate screen provided on atouchscreen display).

If the AMD determines that the requested setting change is not protectedby a passcode, it may permit access to one or more parameter controlelements associated with the requested setting change 3912. In someexamples, once the changes are received via parameter control elements3914, the user may need to provide a second gesture on the userinterface (e.g., touchscreen display) to confirm the changes made. Inresponse to receiving the second gesture 3916, the AMD may change one ormore settings 3918 according to the requested and confirmed changes.

If the AMD determines that the requested setting change is protected bya passcode, it may request a passcode 3920 via a passcode display (e.g.,provided on a touchscreen display). In some examples, the request forthe passcode may be presented on a display but the passcode may bereceived via a physical keypad. Once a passcode is received 3922 fromthe user or subject, the AMD may validate the passcode 3924 by comparingit with one or more user generated passcodes or an override passcode. Ifit is determined that the passcode matches with a user generatedpasscode or an override passcode, the AMD may activate 3926 one or moreparameter control elements associated with the requested setting change.Subsequently, the AMD may receive a setting change via the selectedcontrol parameter element 3928. In some examples, the user may need toprovide a second gesture on the user interface (e.g., touchscreendisplay) to confirm the changes made. In response to receiving thesecond gesture 3930, the AMD may change one or more settings accordingto the requested and confirmed changes 3932.

AMD with Alarm System

In some cases, a condition may occur that impacts the operation of theambulatory medicament device. This condition may be associated with theability of the ambulatory medicament device to operate as intended bythe manufacturer, a subject receiving therapy from the ambulatorymedicament device, and/or user (e.g., healthcare provider, parent, orguardian of the subject). In some cases, the ambulatory medicamentdevice may be operating as intended, but the condition of the subjectmay not satisfy a desired level of health. In either case, it isgenerally desirable to generate an alarm to inform the subject and/orone or more users of the condition of the ambulatory medicament deviceand/or the subject. Moreover, it is desirable to track the alarm untilthe condition that caused the alarm is resolved. Further, it isdesirable to issue different types of alarms for different conditions toenable a subject or user to easily distinguish the severity of thecondition that triggered the alarm. The user may be a subject receivingmedicament or therapy, or may be another user, such as a clinician orhealthcare provider, or a parent or guardian.

This section of the disclosure relates to an ambulatory medicamentdevice, such as an insulin pump or a combined insulin andcounter-regulatory agent (e.g., Glucagon) pump, configured to generate adose control signal configured to cause a medicament pump to infusemedicament into a subject. Moreover, the present disclosure relates toan ambulatory medicament device configured to detect a condition of theambulatory medicament device and/or the subject, and to generate analarm when it is determined that the detected condition satisfies analarm condition.

As mention above, an ambulatory medicament device may include an alarmsystem configured to monitor the ambulatory medicament device and/or thesubject, and to generate an alarm when it is determined that a conditionhas been detected that satisfies an alarm condition. In some examples,the alarm system that may organize a list of alarms, notifying a user ofthese alarms, and allowing the user to acknowledge alarms.

In some embodiments, the alarm system may comprise a plurality ofsensors that monitor the AMD or the subject, a monitoring systeminterface that receives the data from sensors, and alarm generationmodule that process the received data and generate alarms if an alarmcondition is met. In some examples, the monitoring system interface andthe alarm generation module are implemented using one or more hardwareprocessors and machine readable. In some other examples, the monitoringsystem interface and the alarm generation module are separate hard waremodules.

With reference to FIG. 40, in some embodiments, an alarm controlprocedure 4012 implements alarm control procedures in the control andcomputing module (CCM) of the AMD. The alarm control procedure 4012 canbe implemented as instructions stored in a memory of the CCM andexecuted by a hardware processor to generate an alarm upon detection ofa condition of the ambulatory medicament device and/or the subject. Insome cases, the hardware processor of the monitoring system is ahardware processor of the ambulatory medicament device that controlsmedicament delivery. In other cases, the hardware processor of themonitoring system may be a separate hardware processor.

In some examples, the alarm control procedure 4012 includes a monitoringinterface 4016 and an alert generation 4020 system. The monitoringinterface 4016 monitors the condition or status of the AMD and/or thesubject at least partially based on signals or status values receivedform a set of device sensors 4014 and a set of subject sensors 4010. Insome examples, the device sensors may be configured to track the statusof the components or the elements of the ambulatory medicament device,and the subject sensors can be configured to obtain measurements of oneor more physiological characteristics of the subject

In some examples, a device sensor 4014 is a sensor that generates asignal or status value associated with the condition of modules,interfaces, accessories, other modules, interfaces, accessories, ordisposables 4006 of the AMD. In some examples, a device sensor 4014 maygenerate a signal that corresponds to a parameter associated with acomponent in a module or interface. For example, one device sensor mayrecord the voltage of a battery and another device sensor may record thefollow rate of a pump the medicament delivery interface 4004.

In some examples, a subject sensor 4010 may be any sensor that generatesa signal or status value associated with one or more physiologicalindicators (or parameters) of a subject (e.g., heart rate, bloodpressure, body temperature, level of blood sugar, serum levels ofvarious hormones or other analytes). The device and subject monitoringinterface 4016 can include continuously receiving and analyzing signalsreceived from device sensors 4014 and subject sensors 4010 to determinethe condition of the ambulatory medicament device, the subject, asensor, and/or other accessories.

In some cases, a single sensor may be used to monitor both the conditionof the subject and the ambulatory medicament device or accessories andsensors connected to AMD. For example, a continuous glucose monitoringCGM sensor may be used to monitor the condition of the subject, and mayalso be monitored to determine whether the condition of the CGMsatisfies an alarm condition (e.g., to alarm a user that the CGM shouldbe replaced).

Although described as sensors of the ambulatory medicament device, oneor more of the sensors may be accessories that may or may not be part ofthe ambulatory medicament device, but that may communicate with theambulatory medicament device.

In some examples, alarm control procedure 4012 implements procedures forallowing a user 4018 or the subject to change the alarm settings and/oracknowledging an alarm annunciation via the user interface module 4008.In some examples, the user 4018 may be able to see one or more alarmsannunciated on a user interface (e.g., as a list of alarms), even if theAMD is in locked state. In these examples, the user may not be able toacknowledge or respond to alarm when the AMD is in locked state.

In some such examples, a user 4018 or the subject may get access to analarm setting screen or acknowledge an alarm annunciation by providing awake signal and a first gesture (e.g., on a touchscreen display). Insome cases, the first gesture may be created by entering predeterminedcharacters on the alphanumeric pad. In some such examples, the alarmcontrol procedure 4012 distinguishes inadvertent alarm control inputsfrom intentional alarm control inputs. An inadvertent alarm controlinput is an alarm acknowledgment input that was made without the intentof the user 4018 to acknowledge the alarm that the ambulatory medicaldevice is delivering to the user 4018.

In some examples, the alarm control procedure 4012 implements processesfor determination and categorization of an alarm condition based on itsseverity level (e.g., a severity level between 0 and 5), according tothe information received through the monitoring interface 4016.

In some other examples, the alarm control procedure 4012 implementsprocedures for controlling the annunciation of alarm conditions via theuser interface module 4008, at least partially, based on their severitylevel. In some such examples, a user interface (e.g., a touchscreendisplay) may be configured to allow the user 4018 to navigate directlyto the issue or fault for which an alarm is being delivered. Thiscapability provides the user 4018 with access to address the faultcausing the alarm so that it could be corrected thereby stopping thealarm.

Alarm Conditions

In some examples, the device and subject monitoring interface 4016 mayprovide the status information received from the device sensor 4014and/or subject sensors 4010 to the alert generation 4020 system. In someexamples, the status information may comprise one or more status values.In some such examples, the alert generation 4020 system is configured todetermine based at least in part on the status information received fromthe subject monitoring interface 4016, whether an alarm condition issatisfied.

Determining whether the alarm condition is satisfied may includecomparing one or more status values associated with the ambulatorymedicament device and/or the subject to one or more alarm thresholds oralarm conditions. In some cases, each alarm threshold or alarm conditionmay be associated with an alarm profile. In some such cases, determiningwhether the alarm condition is satisfied may include comparing thestatus information to one or more alarm thresholds or alarm conditionsincluded in one or more alarm profiles. In some examples, the alarmprofile may be stored in a storage of the control and computing module.In some such examples, at least some of the alarm profiles may beprovided to the CCM by an authorized user or the subject via a userinterface or directly transferred from another device to the storage(e.g., from USB drive, a laptop, smart phone, PC and the like). In someother examples, at least some of the alarm profiles may be stored in thestorage 218 at the time of manufacture,

Each of the alarm profiles may indicate the characteristics or status ofthe ambulatory medicament device and/or subject that triggers an alarmcorresponding to the alarm profile. For example, at least some alarmprofiles may indicate the threshold status values below of above whichan alarm should be triggered. For example, one alarm profile mayindicate that when a blood glucose level of the subject exceeds aparticular threshold, a particular alarm is to be generated and/orannunciated. As another example, an alarm profile may indicate that whenan available amount of medicament is below a particular threshold, aparticular alarm is to be generated and/or annunciated. The type ofalarm and/or the alarm frequency or intensity associated with themedicament level may differ from the alarm triggered based on the bloodglucose level. Although the previous examples, described a singlecondition associated with a single alarm profile, it should beunderstood that multiple conditions may be associated with an alarmprofile. For example, a blood glucose level that exceeds an upperthreshold or is below a lower threshold may be associated with differentalarm profiles or the same alarm profile. As another example, a bloodglucose level that is above an upper threshold or a medicament pump thatis unable to supply insulin may be associated with the same alarmprofile. On the other hand, a medicament pump that is unable to supplyinsulin due to an empty insulin cartridge may be associated with adifferent alarm profile than if the medicament pump is unable to supplyinsulin due to damage to the medicament pump.

Some non-limiting examples of conditions of the ambulatory medicamentdevice or of the subject that may be associated with an alarm profileinclude conditions relating to a battery capacity (e.g., below athreshold charge capacity or below a capacity associated with aparticular amount of operating time (e.g., one day)), a batterycondition (e.g., high temperature or low voltage), a medicament or drugdelivery condition (e.g., medicament is empty or below a threshold,motor is stalled, catheter is occluded, etc.), subject sensor condition(e.g., blood glucose sensor is expiring, or signal was not received fromsensor), calibration failure, high or low glucose levels, network (e.g.,Bluetooth® or BN-LTE) communication errors, haptic interface errors(e.g., motor non-responsive), speaker errors (e.g., noise or lowvolume), medicament cartridge errors (e.g., empty cartridge, cartridgedetection error, etc.), and the like. As explained below, each of theseerrors or conditions may be associated with different severity levelsthat cause the annunciation of different alarms.

In some cases, each alarm profile may be associated with a severitylevel of the alarm. The severity level may be associated with howurgently the condition that triggered the alarm should be addressed orresolved. Further, the severity level may be associated with an amountof harm that may be caused to a subject if the condition that triggeredthe alarm is not resolved or is not resolved within a particular timeperiod. The number of severity levels may vary based on the type ofambulatory medicament device. Generally, there is no limit to the numberof severity levels. However, there may be a point of diminishing returnsas the number of severity levels exceeds a particular number because,for example, it may be difficult for a user to distinguish between thedifferent numbers of severity levels or to identify with which severitylevel a particular alarm is associated. Thus, the number of severitylevels may be limited to a particular number, such as 3, 5, 6, 9, orsome number in between. However, it is possible for there to be morethan 9 severity levels.

There may be multiple alarm profiles associated with the severity level.Or each condition of the ambulatory medicament device and/or subjectthat is associated with the same severity level may be associated withthe same alarm profile.

The ambulatory medicament device may determine a severity of an alarmcondition based on the condition of the ambulatory medicament deviceand/or the subject that triggered the alarm condition. In some cases,the ambulatory medicament device may determine the severity of the alarmcondition based at least in part on an alarm profile associated with thealarm condition.

Generally, if the alarm condition does not prevent the ambulatorymedicament device from providing therapy, the ambulatory medicamentdevice may continue to provide therapy. However, if the alarm conditioninterferes with the delivery of therapy, operation of the ambulatorymedicament device may be suspended or partially suspended. Generally,alarm conditions that interfere with the provisioning of therapy may beassociated with a higher severity level. However, some alarm conditionsthat interfere with the provisioning of therapy may be associated withlower severity levels. For example, a determination that the ambulatorymedicament device cannot supply insulin may normally be associated witha highest severity alarm. But if a user indicates that the site locationis currently in process of being changed, the alarm condition may beassociated with a lower severity level (e.g., an informational alarmreminding the user that insulin cannot be delivered during site change).

Alarm Annunciation

The alert generation 4020 system can implement an annunciation patternselected based at least in part on the status information generated byand received from the monitoring interface 4016, whether an alarmcondition is satisfied. Determining whether the alarm condition issatisfied may include comparing one or more status values associatedwith the ambulatory medicament device and/or the subject to one or morealarm thresholds or alarm conditions associated with an alarm profile.

Upon verifying that an alarm condition associate with an alarm profileis satisfied, the alert generation 4020 system annunciates the alarmcondition.

In some examples, the alarm system may generate a list of pending alarmconditions and store it in a memory of the AMD. In these examples, anytime an alarm condition associated with an alarm profile is satisfied,the alarm system may update the list of pending alarm condition byadding the new alarm condition to the list of pending alarm conditions.

In some examples, the list of pending alarm conditions may be sortedaccording to the severity level associated with the alarm conditions.

In some examples, the alarm system may annunciate the alarm conditionsvia the user interface module 4008 of the ambulatory medical device1600. For example, the alarm condition may be annunciated via one ormore user interfaces (e.g., a display, a speaker, and the like). In somesuch examples, an alarm may comprise an audio alarm, a text message, agraphical message, a text or graphical message with audio, vibrations,flashing light and any combination of these.

In some other examples, the alarm conditions may be transmitted to otherdevices, via the communication module 4002 of the AMD where, forexample, an authorized user 4018 (e.g., guardians or parents of thesubject), the subject or an emergency provider can view the alarmcondition. In yet other examples, the alert generation 4020 system, mayestablish a direct end-to-end connection with a computing system (e.g.,a cloud computing system) using the communication module 4002 and sendthe alarm condition to the computing system through the end-to-endconnection.

Based on the severity of the alarm condition and/or the alarm profilecorresponding to the alarm condition, an alarm may be generated and/orannunciated that is associated with the severity of the alarm conditionand/or the type of alarm condition. Different alarm conditions and/oralarm profiles may result in different types of alarms or differentannunciations of the alarm. For example, an alarm associated with thehighest severity level may include an audible alarm with a loudness thatexceeds a particular decibel level (e.g., above 70 or 80 decibels), avisible alarm (e.g., a flashing or steady light) with a luminance abovea particular luminance value (e.g., a luminance between 10⁵ or 10⁶candelas per square meter), and/or a vibrational alarm. Further, thealarm associated with the highest severity level may not be snoozed ordismissed. Alternatively, the alarm associated with the highest severitylevel may be snoozed for a shorter time period than alarms of lowerseverity levels (e.g., for 5 minutes, for 10 minutes, etc.). An alarmassociated with a different severity level than the highest severitylevel may include a different combination of audible, visible, andvibrational alarms. Not only may the existence of audible, visible, andvibrational alarms differ for different severity levels, but so may thecharacteristics of each of the alarm types. For example, audible alarmsmay have different sound patterns, loudness, frequencies, etc. Visiblealarm may be of different intensity, color, pattern, etc. Vibrationalalarms may be of different pattern, intensity, etc. Further, an alarmwith a different severity level than the highest severity level may bepermitted to be snoozed or dismisses, or snoozed for a longer period oftime. In some examples, the severity of the alarm condition maydetermine the type of type of the alarm generated (e.g., audio, text,graphical, or any combination of these).

Further, the display of alarm conditions on the user interface mayinclude an icon for each type of alarm condition. The user interface maydisplay the number of alarm conditions and/or the number of alarmconditions of a particular type or severity level. In some cases, aduplicate alarm may be omitted from the list of alarms. In other cases,a count of the occurrence of alarms may be increased to reflect theduplicate alarm. In some cases, a duplicate alarm may result in theannunciation of the duplicate alarm. In other cases, the duplicate alarmis ignored. In some cases, the occurrence of a duplicate alarm may causean escalation of the existing alarm. For example, if an alarm conditionthat causes an annunciation of an alarm with a first severity level isdetected as occurring a second time, the alarm may be annunciated with asecond severity level that indicates a greater degree of severity thatthe first severity level. It should be understood that an alarmoccurring after an alarm condition is resolved may not be considered aduplicate alarm, but instead may be a reoccurrence of the alarmcondition and/or an indicator that the resolution for the alarmcondition failed (e.g., an insulin cartridge replacement is faulty or isempty).\

In some cases, the list of alarms may be accessed when the ambulatorymedicament device is locked. Further, details about the alarms may beaccessible when the ambulatory medicament device is locked.

Each of the alarm conditions, or information associated therewith, maybe added to an indicator or user interface (e.g., a list, or other datastructure or user interface element) that may be accessed by a user.This user interface may maintain the alarm condition on the userinterface until the alarm condition is resolved. Further, the alarmconditions may be sorted or ranked based on the severity level of thealarm condition, the time that the alarm condition occurred, whether thealarm condition relates to the subject or the ambulatory medicamentdevice, any combination of the foregoing, or any other factor forsorting or ranking the alarm conditions.

In some cases wherein the alarm is presented on a display, the displayedinformation may include details about what caused the alarm, theseverity of the alarm, how to respond to or address the alarm, or anyother information that may be informative regarding why the alarm wasgenerated and/or how to respond to the alarm. In some cases, theinformation may provide a workflow or instructions on how to respond tothe alarm. The instructions may include a link to a workflow provided bya manufacturer of the ambulatory medicament device or of another entity,such as an entity that provides medicament or site changing kits.

In some cases, different views of an alarm or different informationassociated with the alarm may be provided based on an identity of theuser, or a role of the user, viewing the alarm. For example, a child maybe instructed to contact a parent to address an alarm. But a parent maybe provided with information to resolve the alarm. The parent mayreceive simplified information (e.g., blood glucose level is high) aboutwhat caused the alarm, but a healthcare provider may receive moredetailed information regarding the alarm (e.g., internal controlparameter values, insulin flow rates, curvature of insulin diminishmentpredictions, etc.) that facilitates the healthcare provider caring forthe subject.

The alarm conditions may be displayed on a display of the ambulatorymedicament device. Alternatively, or in addition, the alarm conditionsmay be displayed on a remote display that is separate from theambulatory medicament device. The remote display may be a display thatis authenticated or associated with a computing device that isauthenticated to access data, such as alarm conditions, from theambulatory medicament device. In some cases, the list of alarms may bepresented on a mobile device (e.g., a smartwatch or smartphone) or on acomputing device (e.g., a laptop or desktop) that can obtain datadirectly or indirectly from the ambulatory medicament device.

In some cases, annunciating the alarm may include contacting amanufacturer and/or user (e.g., a healthcare worker, a parent orguardian, or other registered user). Further, the alarm may includeinstructions on repairing the ambulatory medicament device and/or onaddressing the alarm condition. For example, the alarm may provide auser with instructions to replace the insulin cartridge and how toreplace the insulin cartridge. As another example, the alarm may provideinstructions on how to change the battery of the device or on how tochange a site where the insulin pump connects to the subject. In somecases, the alarm may include one or more operations associated with thealarm. For example, the alarm may trigger reordering of insulin or mayrequest that the user confirm a reorder request to reorder insulin.

A user may be able to acknowledge and/or snooze alarms. Certain alarms,such as informational alarms, may be dismissible. However, generally thealarm may remain on the alarm list until the condition that caused thealarm is resolved.

Resolving the alarm may include any action that addresses the conditionthat caused the alarm to be generated. For example, resolving the alarmmay include replacing an insulin cartridge, changing a site where theambulatory medicament device is connected to the subject, charging abattery of the ambulatory medicament device, providing insulin or acounter-regulatory agent to the subject and/or the ambulatory medicamentdevice, or any other action that may be performed to address an alarmcondition. In some cases, the resolution action may be acknowledging thealarm. For example, if the alarm is informational (e.g., to inform theuser that more insulin has been ordered), acknowledging the alarm may bea sufficient resolution action.

In some cases, whether the alarm condition is resolved may depend on anidentity of the user. For example, if a child interacts with an alarmrelated to reordering of insulin, the alarm may remain until a parent orguardian acknowledges the alarm. However, the child may be able tosnooze the alarm. In some cases, a user interface that displays alarmsmay differ based on who is viewing the alarm. For example, a child mayview the alarms, but may not be able to interact with the alarms.However, a parent or guardian may be able to snooze or dismiss an alarm.Further, a child may be instructed to bring the device to a parent oradult to address an alarm. In some cases, the child may be informed ofhow urgently to contact the parent (e.g., contact a parent immediately,within a day, within a week, etc.). Moreover, a designated adult mayseparately be alarmed (e.g., via a text or email alarm). The parent orguardian may receive additional information not provided to the child orsubject (e.g., a link to repair instructions or a workflow to addressthe alarm condition).

In some cases, certain conditions may self-resolve over time. Forexample, a low battery alarm may resolve as the battery is charged. Insuch cases, the alarm may be cancelled automatically as the batterycharge level exceeds a particular threshold. Further, in some cases, oneor more alarms and/or the alarm list can be viewed and/or accessed on ahome screen, a main screen, or other non-alarm based user interfacescreen in addition to a user-interface screen designated for displayalarms. The alarm list may be accessed from the ambulatory medicamentdevice and/or a computing system in communication with the ambulatorymedicament device.

However, in some cases, the alarm condition may or may not be resolvablewhen the ambulatory medicament device is locked.

A user may interact with the alarms generated based on the alarmcondition. In some cases the user can only interact with the alarms whenthe ambulatory medicament device is unlocked. In other cases, the usercan interact with the alarms to snooze them or to obtain furtherinformation. However, the user may not be able to dismiss the alarmwithout unlocking the ambulatory medicament device. Interacting with thealarms may include providing information associated with the alarm to auser in response to the user interacting with the alarm, or an indicatorrepresentative of the alarm.

Example AMD with Alarm Management System

FIG. 41 shows a flow diagram illustrating an example procedure that maybe used by the alarm system of an AMD to annunciate an alarm conditionupon receiving a status information that satisfies an alarm condition.In some examples, the alert generation 4020 system implements anannunciation process by execution of instructions by a processor in CCMof the AMD, where the instructions can be stored in the main memory,storage of the AMD, or in a memory of a connected electronic device orcomputing system.

The alarm system may receive status information 4102 using the deviceand subject monitoring interface 4016, one or more device sensors and/orone or more subject sensors. In some examples, the alert generation 4020system determines whether the received status information satisfies analarm condition 4104. In some examples, the alarm condition may be analarm condition in an alarm profile. If the received status informationdoes not satisfy an alarm condition, no action may be taken 4106. If thereceived status information satisfies an alarm condition, the alarmsystem may determine whether the alarm condition is already present inthe list of pending alarm conditions or not 4108. If the alarm conditionis not present in the list of pending alarm conditions, the alarm systemmay add the alarm condition to the list of pending alarm conditions4110. Next the alarm system, may determine the severity of the alarmcondition 4112. Based on the determined level of severity, the alertgeneration 4020 system can select an annunciation pattern 4114 andannunciate the alarm condition using the selected annunciation pattern4116. If the alarm condition is present in the list of pending alarmconditions, the alarm system may select an annunciation pattern 4118 andannunciate the alarm condition using the selected annunciation pattern4120. In some examples, the annunciation pattern selected at block 4118,may be an annunciation pattern that is different than the previouslyused annunciation patterns for the alarm condition. In some suchexamples, the annunciation pattern selected at block 4118, may beselected based on number of times that the same alarm condition issatisfied by a received status information. The process of the alarmdetection and control function may repeat each processing cycle so longas the ambulatory medical device is in use. In some examples, after analarm is annunciated, the alarm system may wait for user acknowledgmentof the alarm. If the user acknowledges the alarm, the system proceeds toperform alarm processing. However, if the user fails to acknowledge thealarm, the annunciation continues and may escalate depending on thelevel of the alarm.

As mentioned above, the alarm conditions may be categorized based andannunciated based on their severity level. In some examples, the alarmsare categorized numerically in descending order with the highestpriority fault displayed at the top of the list.

In some examples, a level 0 severity, may be for a trivial fault thatdoes not require any action by the user thus not warranting an alarmnotification. In some other examples, a level 1 severity may be aninformational type notification that repeats at a certain frequency(e.g. every 30 minutes) until acknowledged by user which results in itbeing reset. The annunciation may include a brief vibration and a beep,for example. In some examples, a level 2 severity, may be one relatingto an imminent loss of system function. Thus, such an annunciation mayinclude two brief vibrations and two beeps, for example, and repeatingat a certain frequency (e.g. every 30 minutes). Thus, the user wouldstill need to address the situation creating the fault to completelystop the annunciation. In some other examples, a level 3 fault may befor when the system is no longer fully functional thus requiring userintervention to correct the issue. The annunciation may begin with abase level intensity with three brief vibrations and three audio beeps,for example, and repeating at a certain frequency (e.g. every 5minutes). The annunciation escalates at a second frequency, e.g. every30 minutes, up to a maximum intensity level. The escalation may be achange in vibration intensity and/or audio level, for example. Theescalation may be cleared to base level when the user acknowledges thefault; however, the base alarm remains if underlying condition persists.Thus, the user would still need to address the situation creating thefault to completely stop the annunciation. In some examples, a level 4severity, may be for when the system is no longer functional and notcorrectable by the user. The annunciation may begin with a base levelintensity with three audio beeps, for example, and repeating at acertain frequency (e.g. every 5 minutes). The annunciation escalates ata second frequency, e.g. every 30 minutes, up to a maximum intensitylevel. The escalation may be a change in audio level, for example. Theescalation may be cleared when the user acknowledges the fault; however,the base alarm remains because the underlying condition persists. Insome other examples, a level 5 severity, may be for high priority alarmsper IEC 60601-1-8. The annunciation when activated may be cleared onlywhen the underlying issue is resolved, e.g. glucose level is raised.

Additional embodiments relating to determining a severity of an alarmcondition and annunciating the alarm based at least in part on theseverity of the alarm condition that can be combined with one or moreembodiments of the present disclosure are described in U.S. ProvisionalApplication No. 62/911,017, which was filed on Oct. 4, 2019 and istitled “ALARM SYSTEM AND METHOD IN A DRUG INFUSION DEVICE,” thedisclosure of which is hereby incorporated by reference in its entiretyherein for all purposes.

Non-Critical AMD Condition Management

In some cases, a condition may occur that impacts the operation of theambulatory medicament device. This condition may be associated with theability of the ambulatory medicament device to operate as intended bythe manufacturer, a subject receiving therapy from the ambulatorymedicament device, and/or user (e.g., healthcare provider, parent, orguardian of the subject). In some cases, the condition or malfunction ofthe ambulatory medical device may prevent the ambulatory medical devicefrom providing therapy to the subject. In other cases, the condition ormalfunction may permit, at least for a period of time, the ambulatorymedical device to continue providing at least partial therapy to thesubject. In either case, it is generally desirable to generate an alertto inform the subject and/or one or more users of the condition of theambulatory medical device and/or the subject. Moreover, it is desirableto track the alert until the condition that caused the alert isresolved. Further, it is desirable to issue different types of alertsfor different conditions to enable a subject or user to easilydistinguish the severity of the condition that triggered the alert.

In many cases, if the nature of the alert is non-critical, it may besafer to continue the underlying therapy and notify the user of thecondition than to cease therapy. In some such cases, the best responseto a problem with the device for a subject is to notify the devicemanufacturer, or other user that can address the problem, while thesubject continues to receive therapy until a replacement device can beobtained or a repair can be made.

Additionally, alert fatigue can be an issue with medical devices due toexcessive alerts which do not necessarily require user interaction.Alert fatigue can be dangerous because it can lead users to ignoreserious alerts or alerts that require action in the short term.

The method described herein may be performed by an AMD (e.g., by one ormore processor of the AMD) to detect device malfunctions for the AMD andthat can generate alerts corresponding to the ambulatory medical deviceand prioritize the alerts to enable the subject or user to quickly andeasily determine whether the device malfunction will impact therapy,should be addressed in the short-term (e.g., immediately, in 1-2 hours,within the day, etc.), and/or can be addressed at the subject'sconvenience (e.g., within a month, or more). In some cases, the methodmay be used by other systems.

In certain embodiments, the system disclosed herein can detect acondition in which the ambulatory medical device does not meet amanufacturer's specification (e.g. a failure of a haptic annunciator, aBluetooth® radio malfunction, glucagon or insulin runs out, there is amedicament delivery malfunction, a touchscreen failure, etc.). In somecases, there can be several tiers of critical and/or non-criticalfaults. If it is determine that the underlying condition is notsufficient to stop therapy (e.g., delivery of insulin is not stopped),the fault may be deemed non-critical. In some cases, the fault may notbe a fault of the device, but may be indicative of required maintenance(e.g., recharge battery indicator, order more medicament indicator,etc.). The condition may be annunciated to the user with appropriateinstructions (e.g., call manufacturer for replacement medicament orparts) for addressing the fault or issue.

After the annunciation is acknowledged, the alert may be re-annunciatedas a reminder at some later period in time (e.g. the alert may bere-annunciated daily at 4:00 PM or on Saturdays at noon). The length oftime between annunciations may depend on the severity of the fault. Insome cases, the re-annunciation cannot be stopped by the user, but mayonly cease if the underlying condition is resolved.

The method may include detecting a condition of the ambulatory medicaldevice. The condition of the ambulatory medical device may be determinedby one or more sensors of the ambulatory medical device. Further, thecondition of the ambulatory medical device may be determined by thepresence or absence of one or more errors when performing one or morefunctions of the ambulatory medical device. For example, if theambulatory medical device fails to establish a communication connectionwith a control system or a data storage system, it may be determinedthat there is a possible malfunction with the ambulatory medical device.As another example, if the ambulatory medical device fails to delivermedicament or detects an error when attempting to deliver medicament,there may be a malfunction with the medicament pump. In some cases, thecondition of the ambulatory medical device may be determined based onone or more configuration values being outside a normal operating range.For example, if the speed of delivery of medicament is faster or slowerthan a configured operating range, then it may be determined that thereis a malfunction with the medicament pump or a connection with amedicament delivery tube (e.g., a catheter).

The method may include comparing the detected condition of theambulatory medical device to a set of normal operating parameters. Theset of normal operating parameters may be the specifications set by themanufacturer for when the ambulatory medical device is operating asintended by the manufacturer. In some cases, the normal operatingparameters may be associated with a range of values. For example, theoperating parameter for a speed of medicament delivery may be associatedwith a range of speeds, which may vary based on user settings,medicament type, site location of medicament delivery, or manufacturingtolerances, among other parameters. Comparing the detected condition ofthe ambulatory medical device to the set of normal operating parametersmay include comparing each operating parameter in the specification to acorresponding detected operating parameter of the ambulatory medicaldevice. The ambulatory medical device may generate a user alert based onthe determined condition of the ambulatory medical device. For example,the AMD may generate an alert when the detected condition of theambulatory medical device does not satisfy a set of normal operatingparameters.

The method may further include determining whether the detectedcondition satisfies a minimum set of operating parameters. In somecases, the minimum set of operating parameters may match the normaloperating parameters. However, typically the minimum set of operatingparameters differ from the normal operating parameters. The minimumoperating parameters may include the minimum specifications, minimumparameters, or minimum condition required by the ambulatory medicaldevice to maintain or continue providing therapy to the subject. Inother words, the minimum operating parameters are the operatingparameters sufficient to provide therapy. However, the minimum operatingparameters may not be sufficient to enable all features of theambulatory medical device. For example, the minimum operating parametersmay permit the ambulatory medical device to deliver insulin to thesubject, but may not be sufficient to deliver the insulin at a normaldelivery speed for the particular ambulatory medical device. As anotherexample, the minimum operating parameters may permit the delivery oftherapy, but may not be sufficient to track a log of therapy or totransmit a therapy log to another computing system. In some cases thenormal operating parameters and/or minimum operating parameters may bespecified by a subject or healthcare provider (e.g., the minimum amountof medicament that is to be provided in each bolus may be specified by ahealthcare provider). In some cases, the normal or minimum operatingparameters may be modified.

When it is determined that the condition of the ambulatory medicaldevice satisfies at least the minimum operating parameters, theambulatory medical device may be configured to maintain delivery oftherapy to the subject. Maintaining delivery of therapy may includemaintaining therapy at the same rate, at a reduced rate (e.g., providingonly basal therapy and therapy responsive to a meal announcement), or ata minimum maintenance rate (e.g., providing only basal insulin).Advantageously, the ability of the ambulatory medical device todistinguish between a minimum set of operating parameters and a normalset of operating parameters enables an ambulatory medical device with amalfunction to continue providing therapy, which sometimes includeslife-saving treatment, to a subject until the ambulatory medical devicecan be repaired or until the condition of the device worsens to a pointwhere the minimum operating parameters cannot be maintained. In somecases, the ambulatory medical device may temporarily maintain deliveryof therapy. Temporarily maintaining therapy may provide a subject timeto address the issue that caused the ambulatory medical device to notsatisfy the normal operating parameters before the subject loses accessto therapy. In some cases, the ambulatory medical device temporarilymaintains therapy until the device condition makes it no longer possibleto maintain therapy.

FIG. 42 is a block diagram illustrating the interconnection amongmodules and procedures in AMD involved in monitoring the condition ofthe AMD and generating an alert when a device malfunction is detected.In some examples, the condition of AMD may include the status of themodules and components of the AMD, such as AMD modules and sensors 4204and/or operation of modules and procedures of the AMD. In someembodiments, the alert system may be implemented as a set of alertcontrol procedures 4208 in the control and computing module (CCM) of theAMD. The alert control procedures 4208, may be implemented asinstructions stored in a memory of CCM and executed by a hardwareprocessor to generate an alert upon detection of a malfunction of theambulatory medicament device. In some cases, the hardware processor maybe a hardware processor of the ambulatory medicament device thatcontrols medicament delivery. In other cases, the hardware processor ofthe monitoring system may be a separate hardware processor.

In some examples, the alert control procedures 4208 may include amonitoring interface 4214, an operation monitoring procedure 4212 andalert generation procedure 4216. The monitoring interface 4214 maymonitor and evaluate the condition of the AMD and/or the subject atleast partially based on the information received from the operationmonitoring procedure 4212 and device sensors 4210. In some examples, thedevice sensors may be configured to track the status of the componentsor the modules of the ambulatory medicament device and the operationmonitoring procedure 4212 may be configured to monitor the operation ofthe modules and other procedures. In some examples, the detected of theAMD may be provided to the alert generation procedure monitoringinterface. The alert generation procedure 4216 may compare the detectedcondition of the AMD with a set of normal operating parameter. In someexamples, the alert generation procedure may also determine whether thedetected condition of the AMD satisfies a minimum set of operatingparameters. In some examples, if it is determined that the detectioncondition of the AMD does not satisfy the normal operating parameters,the alert generation procedure may generate an alert. In some examples,the alert may be transmitted to the user interface module 4206 anddisplayed on a display of the AMD (e.g., a touchscreen display). In someother examples, once an alert is generated the AMD may establish aconnection (e.g., a wireless connection) with another device. This otherdevice may include a local device (e.g., a laptop, smartphone orsmartwatch of the user) or a computing system of a cloud-based service.In some such examples, the alert may be transmitted by the communicationmodule 4202 to the computing systems where it may be displayed on userinterface associated with the computing system. In some cases, theadditional device may receive data from the ambulatory medical deviceenabling it to monitor the condition of the ambulatory medical device.

The type of the alert, and the frequency at which the alert is repeated,or whether an alert is dismissible or not, may be determined by thealert generation procedure based on the detected condition of the AMDand the alert information stored in a memory of the AMD. In someexamples, the alert information may be provided by the subject, anauthorized user or a healthcare provider. In some other examples, thealert information may be stored in the AMD at time of manufacturing.

In some examples, upon determination that the detected AMD conditiondoes not satisfy a set of normal operating parameters, the alertgeneration procedure may cause the medicament delivery interface to stoptherapy delivery or modify one or more delivery parameters (e.g.,therapy delivery rate). In some examples, upon determination that thedetected AMD condition does not satisfy a set of normal operatingparameters, but satisfies a set of minimum operating parameters, thetherapy delivery may be maintained at a normal rate.

The alert may include any type of alert. For example, the alert may be avisual alert (e.g., a light or changing light), an audible alert (e.g.,a beep or series of beeps), a haptic or vibration alert, an email alert,a text alert, or any other type of alert. Different device conditionsmay be associated with or may trigger different alerts. Thus, the useralert may enable the user to determine the device condition of theambulatory medical device based on the alert. For example, an indicationthat the ambulatory medical device failed to deliver a medicament maytrigger one type of alert while an indication that the ambulatorymedical device has below a particular level of medicament available maytrigger a different alert. In some cases, the user alert is dismissibleand/or may be snoozed by the user. In other cases, such as when theambulatory medical device fails to satisfy a set of minimum operatingparameters, the user alert may not be dismissible or cannot be snoozed.

A dismissible alert may be scheduled to repeat on a particular scheduleuntil an alert modification condition occurs. The frequency with whichthe dismissible alert repeats may depend on the severity of thecondition or the particular operating parameters that do not satisfynormal or minimum operating parameters. More urgent device conditionsmay result in alerts that repeat more frequently. Further, alerts mayvary based on when the condition was detected, the time of day, or thedetected activity of a subject (e.g., sleep, abnormal activity, orelevated activity, such as exercise). Similarly, the snooze options mayvary for different alerts or any of the aforementioned conditions. Insome cases, the ambulatory medical device may escalate an alert if itdetects that the condition of the ambulatory medical device has becomemore critical.

The alert frequency may be for a static time period (e.g., every 5hours) or may ramp towards more frequency (e.g., every 5 hrs for 1 to 3reminders, every 4 hours for 3 to 6 reminders, etc.), or may changebased on time of day (e.g., snooze alerts during sleeping hours fornon-urgent alerts), etc.

The alert modification condition may include any action that causes theoperating parameters of the ambulatory medical device to return tonormal operating parameters. For example, the alert modificationcondition may be a repair or replacement of a faulty component. In somecases, the alert modification condition may comprises an acknowledgementof the alert. In other cases, the alert modification condition mayinclude a worsening of the ambulatory medical device condition. In suchcases, the modification to the alert may include the substitution of thealert to a different alert that indicates a different or more seriouscondition of the ambulatory medical device. For example, an urgentcondition may become critical if the detected malfunction is addressedafter generating certain number of alerts. When an urgent conditionbecomes critical, it may trigger a different alert type (e.g., a loudersound, or brighter image) and/or escalation in the alert frequency. Forexample, the audible alert may become louder and may be combined with avibration alert from a haptic annunciator. Moreover, if the conditionreaches a critical state, the ambulatory medical device may ceaseproviding therapy to the subject.

In some cases, generating the alert may further include contacting amanufacturer and/or healthcare provider (e.g., clinician). Further,generating the alert may include ordering replacement parts. In somecases, the alert may instruct a subject or user on how to repair theambulatory medical device.

Once the malfunction is addressed, the ambulatory medical device isrepaired, or the condition that caused the alert is resolved, a user maypermanently (or until the next time a device condition triggers thealert) dismiss the alert. Alternatively, or in addition, the ambulatorymedical device may automatically dismiss the alert if it senses that thedevice condition that caused the alert has been resolved. In some cases,the ambulatory medical device may periodically recheck the devicecondition to determine whether the alert condition has been resolved.

In some cases, the manufacturer or healthcare provider may remotelyclear or stop an alert using, for example, an NB-LTE connection. In somecases, only the manufacturer and/or healthcare provider can clear orstop the alert. Further, in some cases, a manufacturer and/or ahealthcare provider may notify a user (e.g., a subject, or parent orguardian) of an issue or impending issue with the ambulatory medicaldevice. The notification may be received by the ambulatory medicaldevice via the NB-LTE connection. Alternatively, or in addition, thenotification may be received via a computing device, such as asmartphone or laptop.

FIG. 43 is a flow diagram illustrating an example procedure that may beused by the alert system of an AMD to monitor the operation of an AMDand generate alerts when a device malfunction is detected. In someexamples, the alert system continuously monitors the status of allmodules and components associated with AMD as well as the operation ofall modules and procedures of the AMD. When a device condition isdetected 4302, the alert system may determine whether the detecteddevice condition satisfies a set of normal operating parameters 4304. Ifit is determined that the detected device condition satisfies a set ofnormal operating parameters, the alert system takes no action andcontinuous monitoring the AMD. If it is determined that the devicecondition does not satisfy a set of normal operating parameters, thealert system determines whether the detected device condition satisfiesa set of minimum operating parameters. If, at block 4306, it isdetermined that the device condition does not satisfy a set of minimumoperating parameters, the alert system may send a signal to the therapydelivery module to stop delivery of therapy to the subject 4308, andimmediately generate a critical user alert 4312 indicating thatimmediate action is required. In some examples, upon generation of acritical alert the alarm system of the AMD, may contact a healthcareprovider or certified user (e.g., parent or guardian of the subject) andalso send the critical alert to one or more computing devices (e.g.,laptop, cell phone, personal computer, and the like) of the healthcareprovider or certified user. If, at block 4306, it is determined that thedevice condition satisfies a set of minimum operating parameters, thealert system may maintain the delivery of therapy to the subject 4310and generate a user alert 4314. In some such examples, the alert systemmay maintain the delivery of the therapy at rate associated with thedetected condition of the AMD (e.g., normal rate or minimum maintenancerate) until an alert modification condition is detected 4316. Upondetection of an alert modification condition 4316, the alert system maydetermine whether the new device condition satisfies a normal setparameters 4318. If, at block 4318, it is determined that the new devicecondition satisfies a set of normal operating parameters, the alertsystem may resume the normal operation of the AMD 4320 (e.g., deliverthe therapy at a normal rate). If at block 4318, it is determined thatthe new device condition does not satisfy a set of normal operatingparameters, the alert system may determine whether the new devicecondition satisfies a minimum set parameters 4322. If, at block 4322, itis determined that the new device condition satisfy a set of minimumoperating parameters. The alert system may maintain or modify the rateof therapy delivery according to the new device condition 4326 andgenerate a user alert 4330 according to the according to the new devicecondition. If, at block 4322, it is determined that the new devicecondition does not satisfy a set of minimum operating parameters, thealert system may send a signal to the therapy delivery module to stopdelivery of therapy to the subject block 4324, and immediately generatea critical user alert 4328 indicating that immediate action is required.In some examples, upon generation of a critical alert the alarm systemof the AMD, may contact a healthcare provider or certified user (e.g.,parent or guardian of the subject) and also send the critical alert toone or more computing devices (e.g., laptop, cell phone, personalcomputer, and the like) of the healthcare provider or certified user.

Managing Doses of Glucose Control Agents

Ambulatory medical devices allow subjects the freedom to treatthemselves while being mobile. Self-managed medical treatment comes withinherent risks to the subject.

An automated blood glucose control system may automatically provideinsulin and/or a counter-regulatory agent (e.g., Glucagon) to a subjectto help control the blood glucose level of the subject. Generally, acontrol algorithm is implemented by an automated blood glucose controlsystem (BGCS) to determine when to deliver one or more glucose controlagents and how much agent to provide to the subject. Further, thecontrol algorithm may control both an ongoing or periodic delivery ofinsulin (e.g., a basal dose), and a correction bolus that may beprovided to adjust a subject's blood glucose level to within a desiredrange. The control algorithm may use blood glucose level readingsobtained from a sensor, such as a continuous glucose monitoring (CGM)sensor, that obtained automated blood glucose measurements from thesubject. Moreover, in some cases, the control algorithm may deliver abolus of insulin in response to an indication of a meal to be consumedor being consumed by the subject.

Insulin may be administered subcutaneously into blood of a subject.There is often a delay between when the insulin is provided and when theamount of insulin in the subject's blood plasma reaches maximumconcentration. This amount of time may vary based on the type of insulinand on the physiology of the particular subject. For example, with afast-acting insulin, it may take approximately 65 minutes for a bolus ofinsulin to reach maximum concentration in the blood plasma of thesubject. For some other types of insulin, it may take anywhere from 3-5hours to reach maximum concentration in the blood plasma of the subject.Accordingly, the blood glucose control system may implement a predictivealgorithm that implements a bi-exponential pharmacokinetic (PK) modelthat models the accumulation of insulin doses in the blood plasma of thesubject. The blood glucose control system may modify its predictionsbased on the type of insulin, one or more blood glucose readings, and/orcharacteristics of the subject.

In some cases, a subject may receive a manual bolus of insulin ormedicament. For example, a user (e.g., healthcare provider, parent, orguardian) or subject may inject a dose of insulin into the subject. Asanother example, the user or subject may manually direct the automatedblood glucose control system to provide a bolus of insulin to thesubject.

It is generally undesirable to have too much insulin. An excess ofinsulin can lead to Hypoglycemia. As described above, it may take timefor insulin to reach maximum concentration in the blood plasma of thesubject. Thus, a blood glucose level reading from a sensor may notimmediately, or even after a particular period of time, reflect theamount of insulin within a subject. Thus, a manual bolus of insulin maynot be detected by the automated blood glucose control system. As aresult, if the automated blood glucose control system is operatingduring delivery of a manual bolus, or is configured to operate on thesubject prior to blood glucose level readings reflecting the effect ofthe manual bolus on the subject, the automated blood glucose controlsystem may unnecessarily administer additional insulin to the subjectpotentially leading to hypoglycemia.

The present disclosure relates to an automated blood glucose controlsystem configured to provide automatic delivery of glucose controltherapy to a subject and receive information about manual glucosecontrol therapy provided to the subject. Using the received informationabout the manual glucose therapy, the automated blood glucose controlsystem can adjust the blood glucose control algorithm to account for themanual dosing of insulin (or counter-therapy agents). The manual glucosecontrol therapy may be provided by injection therapy, or it may beprovided by an insulin pump.

In some cases, the automated blood glucose control system may receive anindication of insulin or medicament to administer to a subject in placeof an automatically calculated dose of insulin. For example, theautomated blood glucose control system may receive an indication that asubject is consuming or will consume a meal. The indication may includea type of meal to be consumed (e.g., breakfast, lunch, or dinner) and anestimate of the quantity of food or carbohydrates to be consumed (e.g.,less than usual, a usual amount, more than usual, 30-40 grams ofcarbohydrates, 45-60 grams of carbohydrates, etc.). Based on theindication, or meal announcement, the automated blood glucose controlsystem may calculate an amount of insulin to administer to the subject.The calculation may be based on an insulin to carbohydrate ratioprovided by a clinician and/or determined by the automated blood glucosecontrol system. Moreover, the calculation may be based at least in parton a history of blood glucose level measurements for the subject whenconsuming particular meals.

The calculated amount of insulin for the meal announced by the user maybe presented to the user. The user (e.g., the subject) may modify theamount of insulin to administer. For example, the user may determinethat for the size meal the subject is consuming or planning to consume,more or less insulin should be administered. In such cases, the user maymodify the calculated insulin dosage to match the user's determinationof the amount of insulin to administer. In some cases, the automatedblood glucose control system may modify its control algorithm based onthe user's input. Thus, future meal announcements may result in acalculation of insulin that satisfies the subject's insulin needs and/orpreferences.

In some cases, the indication of an amount of a manual bolus may bereceived by a user entering a numerical value (e.g., an amount ofinsulin, a number of carbohydrates, or another calculation) associatedwith administering insulin. As described above, the automated bloodglucose control system may automatically-calculate a meal dose ofinsulin and present it to a user via a user interface where a user mayenter the manual bolus information. At the time of making the mealannouncement, the user may have an option to enter the manual bolus. Themeal controller of the blood glucose pump can provide a recommendationagainst the manual entry if there is a prior history of online operationor a basis for making the recommendation.

The information may be received from a user via a user interface. Thisuser interface may be provided by the automated blood glucose controlsystem. Alternatively, or in addition, the user interface may begenerated by another device, such as a laptop or desktop, a smartphone,a smartwatch, or any other computing device that can communicate viawired or wireless communication with the automated blood glucose controlsystem. The information may include one or more of: an indication ofdelivery of a manual bolus (e.g., via injection therapy), an amount ofthe manual bolus, a type of the insulin (or other medicament), a timewhen the manual bolus was delivered, a general location that the manualbolus was administered to the subject (e.g., back, stomach, arm, leg,etc.), a reason for the manual bolus (e.g., a meal, a maintenance dose,a blood glucose level reading, in advance of exercise, etc.), and anyother information that may be useable by the blood glucose controlsystem in controlling the blood glucose level of the subject.

Advantageously, in certain embodiments, providing manual dosinginformation to the automated blood glucose control system can help theblood glucose control system maintain the blood glucose level of thesubject within a desired range when the automated features of the bloodglucose control system are active or operational. For example, if theautomated blood glucose control system determines from a CGM sensorreading that a subject's blood glucose level is high, the automatedblood glucose control system might normally administer a bolus ofinsulin. However, if the automated blood glucose control system receivesan indication that a manual bolus of insulin was administered recently(e.g., within the past thirty minutes), the automated blood glucosecontrol system may reduce or not administer a bolus of insulin, therebypreventing a Hypoglycemic event. In some such cases, the automated bloodglucose control system may continue monitoring the blood glucose levelof the subject and may administer additional insulin at a later time ifthe blood glucose level readings do not reflect an expected bloodglucose level based on the reported manual bolus of insulin.

In some cases, it may be unnecessary to receive an indication of themanual bolus because, for example, a user may cause the automated bloodglucose control system to provide the manual bolus. In such cases, theautomated blood glucose control system may track the amount of insulindelivered and the timing of the administering of the bolus. To track themanual bolus, the automated blood glucose control system may store theinformation associated with the manual bolus in a therapy log.Accordingly, when the automated blood glucose control system isoperating in an automatic mode, the automated blood glucose controlsystem can access the therapy log to determine whether any manual boluswere administered and, if so, the timing and amount of the manual bolus.

In some cases, the automated blood glucose control system may model thediminishing of insulin, or other medicament, in the blood plasma overtime based on the information associated with the manual bolus. Modelingthe diminishing of medicament over time may be used to estimate a futureeffect of the medicament previously administered. In some cases, themodel may account for previously administered medicament by theautomated blood glucose control system. Further, in some cases, themodel may account for physiological characteristics of the subject, suchas the subject's weight or an input parameter related to the subject'sweight (e.g., body mass index). Moreover, the model may account forperfusion over time of the medicament bolus from a subcutaneous infusionsite into the blood plasma of the subject. Further, the automated bloodglucose control system may model an accumulation of insulin, model timecourse of activity of insulin, or model a finite rate of utilization ofinsulin.

Based on the model, the automated blood glucose control system mayadjust the automated administering of insulin, or other medicament whenoperating in an automatic mode. Further, the automated blood glucosecontrol system may operate the administering of medicament (e.g., bycontrolling a medicament pump) based on a glucose level of the subjectand the modeled concentration of medicament in the subject.

In some cases, the automated blood glucose control system may confirmthat the manual bolus was delivered to the subject. The confirmation maybe determined based at least in part on whether blood glucose levelreadings by the CGM sensor match or are within a threshold levelanticipated by the automated blood glucose control system based on themanual dosing information. Alternatively, or in addition, the automatedblood glucose control system may request, via a user interface, that auser confirm that the manual bolus was delivered. In cases where themanual bolus in delivered by the automated blood glucose control system,a user may be requested to confirm the administering of the manual bolusby using a particular gesture or sequence of interactions with a userinterface (e.g., a touchscreen) of the automated blood glucose controlsystem or of a device (e.g., laptop or smartphone, etc.) thatcommunicates with the automated blood glucose control system.

As previously described, in some cases, the information relating to themanual bolus may include an amount of insulin and a reason the manualbolus was administered (e.g., for a meal of a particular size). In somesuch cases, the automated blood glucose control system may determine anamount of insulin the automated blood glucose control system wouldadminister in an automatic operating mode based on the manual dosinginformation if the manual bolus had not been supplied. If the automatedblood glucose control system determines it would have supplied adifferent quantity of the medicament, and if the difference exceeds athreshold, the automated blood glucose control system may adjust a bloodglucose control algorithm to account for the difference. For example,the automated blood glucose control system may change the operatingsetpoint or range of insulin the automated blood glucose control systemattempts to maintain in the subject. As another example, the automatedblood glucose control system may supplement the manual bolus withadditional insulin to account for an under-administering of insulin, ormay reduce a subsequent dosage of insulin to account for anover-administering of insulin.

As previously indicated, the automated blood glucose control system maymaintain a therapy log of manual insulin therapy. This therapy log maybe maintained based on the use of the automated blood glucose controlsystem to provide a manual bolus, or based on information provided bythe user based on manual administering of insulin (e.g., via injection).The manual boluses may be supplied when the automated blood glucosecontrol system is not operating, is not operating in an automatic mode,or is not connected to the subject. Once the automated blood glucosecontrol system is connected to the subject and is configured inautomatic mode, the automated blood glucose control system may determinetherapy, if any, to provide to the subject based on a combination of thetherapy log and the glucose control algorithm implemented by theautomated blood glucose control system.

The automated blood glucose control system may generate a dose controlsignal based on the determined therapy. This dose control signal may besupplied to a medicament pump, which may control delivery of themedicament (e.g., insulin) to the subject.

In some cases, a user may control whether the automated blood glucosecontrol system is operating in a manual mode or an automatic mode byinteracting with a user interface of the automated blood glucose controlsystem or of a device that communicate with the automated blood glucosecontrol system. The user interaction may include any type of userinteraction with a user interface. For example, the user interaction mayinclude interaction why physical buttons or interactions with atouchscreen including gestures or taps on the touchscreen.

Additional embodiments relating to managing meal medicament doses andmanual dosing that can be combined with one or more embodiments of thepresent disclosure are described in U.S. Provisional Application No.62/911,143, which was filed on Oct. 4, 2019 and is titled “SYSTEM ANDMETHOD OF MANAGING MEAL DOSES IN AN AMBULATORY MEDICAL DEVICE,” thedisclosure of which is hereby incorporated by reference in its entiretyherein for all purposes.

A system of one or more computers can be configured to performparticular operations or actions by virtue of having software, firmware,hardware, or a combination of them installed on the system that inoperation causes or cause the system to perform the actions. One or morecomputer programs can be configured to perform particular operations oractions by virtue of including instructions that, when executed by dataprocessing apparatus, cause the apparatus to perform the actions. Onegeneral aspect includes a method including: providing an option to auser to select between receiving medicament using a manual deliverycomponent or an automated delivery system. The method also includesreceiving, by the automated delivery system, subjective informationregarding the activity or action that may alter the blood-glucose level.The method also includes receiving, by the manual delivery component, anamount of the medicament to be infused. The method also includes storinga time and the amount of medicament that is infused into the automateddelivery system that controls blood glucose level. Other embodiments ofthis aspect include corresponding computer systems, apparatus, andcomputer programs recorded on one or more computer storage devices, eachconfigured to perform the actions of the methods.

Implementations may include one or more of the following features. Themethod where the automated delivery system modifies medicament deliverybased on the time and the amount of medicament that was received fromeither the manual delivery component or the automated delivery system.The method where the manual delivery component includes a keypad whichallows the user to type in the dosage amount of the desired medicament.The method where providing the option to select is provided prior to auser performing the activity that may alter the blood-glucose level. Themethod where the activity that may alter the blood-glucose levelincludes of consuming food or exercising. The method where thesubjective information regarding the activity of consuming food includesthe approximate relative size of the food that is to be digested. Themethod where the approximate relative size of the food is compared tothe recommended meal doses for the user, and depending on whether theapproximate relative size is the same, larger, or smaller than therecommended doses, the model predictive control component is able todetermine the actions that is required to regulate the glucose level ofthe blood. The method where the subjective information regarding theactivity of exercising includes the intensity and the duration of theexercise. The method where the intensity and the duration of theexercise is compared to the recommended intensity and duration, anddepending on whether it is the same, larger, or smaller than therecommended intensity and duration, the automated delivery system isable to determine the actions that is required to regulate the glucoselevel of the blood. Implementations of the described techniques mayinclude hardware, a method or process, or computer software on acomputer-accessible medium.

One general aspect includes a system having a medical device configuredto provide an option to a user to select between receiving medicamentusing a manual delivery component or an automated delivery system. Thesystem also includes automated delivery system configured to receivesubjective information regarding the activity that may alter theblood-glucose level. The system also includes a manual deliverycomponent configured to receive an amount of the medicament to beinfused. The system also includes where the medical device storing atime and the amount of medicament that is infused into an automateddelivery system that controls blood glucose levels. Other embodiments ofthis aspect include corresponding computer systems, apparatus, andcomputer programs recorded on one or more computer storage devices, eachconfigured to perform the actions of the methods.

Upon utilizing an ambulatory medical device to request for a therapychange, users may have different preferences. Therefore, it is desirablefor modern technology, specially the ambulatory medical devices to beequipped with optionality features. These optionality features mayfulfill the different preferences of the users and subjects. Theoptionality features may allow users to control the therapy changes moreclosely and may allow them to be more engaged with the medicalassistance of the ambulatory medical device.

In order to fulfill the variety of preferences, an ambulatory medicaldevice needs to provide options which allows the user to either manuallyrequest the amount of the desired medicament or chose an automateddelivery system that automatically delivers the right amount of themedicament at the right time without further assistance. For the manualcomponent, the user may personally input the desired amount on a keypadthat is provided by the medical device. The medical device furtherconfirms and delivers the requested medicament. After the medicament isinfused through a manual delivery component, the data is stored into amodel predicative control component which is further used to control andregulate the blood glucose level. However, if the user decides to usethe automated delivery system, the user must provide subjectiveinformation regarding the activity or the action that may alter theblood-glucose level. For example, if the blood-glucose level changingactivity is consuming food, the user must provide the time and thedosage amount of the food that is going to be digested. This informationis tied to the automated delivery system, and the subjective informationis further stored into a model predicative control component.

Embodiments described herein include an ambulatory medical device thathas a keypad which allows a user to type in a dose of insulin orglucagon to be administered to a user. A user may wish to receive asingle dose of insulin prior to consuming food and decide how muchinsulin need to be administered. In other embodiments, the user maychoose to receive a burst of glucagon due to low blood sugar because ofphysical activities. Embodiments may include the options for manualinputs of medicament and automated delivery system of medicament. Invarious implementations, the automated delivery system of medicament isdriven by the blood glucose level or related trends. Embodiments hereinaddress a problem that may arise when the user has just received amanual dose and has switched on the automated delivery system. In suchcases, the automated delivery system may be made aware of all manualmedicament infusion amounts and the timing of such infusions.Accordingly, the manual delivery component may inform the automateddelivery system upon delivering any medicament the type of medicamentdelivered, the amount of medicament and the timing of the medicamentdelivered. By having the above information, the automated deliverysystem may determine the amount of medicament that is the user's bloodstream and adjust the automated delivery of medicament and the timing ofthe automated delivery. Accordingly, embodiments are directed to allowsfor a risk free transition from the manual delivery component and theautomated delivery system.

Differences from other system may include that the manual delivery maybe tied to an automated delivery system, the dose input from the user isthen stored into the MPC algorithm (Model Predictive Control) instead ofthe meal delivery algorithm and is handled by the MPC algorithm. Otherembodiments may include selection being able to have a relativisticalgorithmically tuned value. Other embodiments may include a learningalgorithm that includes a usual size meal or larger size meal or smallsize meal. Embodiments may include correlating the manual inputs toasking the user what was the size of the meal and learning how theinsulin affects the user. Embodiments may include correlating the manualinputs to asking the user what activity the user performed and learninghow the glucagon affects the user for a particular activity.

BGCS with Manual Dose Management

FIG. 44 illustrates a schematic of the therapy change delivery system4400 in an ambulatory medical device 4402 that allows the user thechoice of receiving manual delivery of medicament or automated deliveryof medicament. Moreover, the therapy change delivery system 4400 allowthe user to transition between the manual mode and the automated modewith ease. The therapy change delivery system 4400 includes theambulatory medical device 4402, a signal processing component 4404, auser 4406, a therapy delivering component 4408, a therapy change input4410, input components 4412, activity change component 4414, and atherapy change delivery 4416. When the user intends to receive a therapyfrom an ambulatory medical device 4402, the user 4406 may initiate atherapy change input 4410 to request the manual or automated medicament.

The ambulatory medical device 4402 is any medical device that a user4406 may carry around and use with the approval of a medicalprofessional. There are many different types of ambulatory medicaldevices 4402. In one embodiment, the ambulatory medical device 4402 isan insulin and/or glucagon infusion device for user 4406 that have typeI diabetes. Ambulatory medical devices 4402 allow users 4406 the freedomto receive medical care in any setting at their convenience. However,the drawback of using an ambulatory medical device 4402 could be theuser 4406 making mistakes when the user is away from the medicalprofessionals. One possible issue may be caused the user 4406 switchesfrom a manual delivery mode to an automated delivery mode when theautomated delivery mode is unable to determine the amount of medicamentin the user's blood stream. Embodiments are directed to the manualmedicament delivery information being provided to the automatedmedicament delivery system so that it can adjust its operations based onthe current and future medicament in the user's blood stream. In somecases, such as the embodiment where the ambulatory medical device 4402is an insulin and/or glucagon infusion device, doing automated deliveryof medicament can be problematic.

The ambulatory medical device 4402 includes a signal processingcomponent 4404, a therapy delivering component 4408, and inputcomponents 4412. The signal processing component 4404, therapydelivering component 4408, and input components 4412 may be physicallyconnected, wirelessly connected, connected via a cloud-based computersystem, or connected in any other way.

The signal processing component 4404 is a computing system that performsthe computing functions for the ambulatory medical device 4402. Thesignal processing component 4404 includes a processor, memory, andstorage. The signal processing component 4404 may be a single computingsystem or may be made up of several computing systems. The signalprocessing component 4404 may perform the computing functions for asingle ambulatory medical device 4402 or many ambulatory medical device4402. The signal processing component 4404 receives signals from thetherapy delivering component 4408 and from the input components 4412.The signal processing component 4404 also transmits signals to thetherapy delivering component 4408 and the input components 4412. Signalsof the therapy change input 4410, the therapy change delivery 4416, andall steps of the activity change component 4414 may be received ortransmitted by the signal processing component 4404.

The user 4406 is any individual that uses the ambulatory medical device4402. In one embodiment the user 4406 is an individual with diabetesthat requires a periodic infusion of insulin or glucagon to maintainhealthy blood sugar levels. In various embodiments, the ambulatorymedical device 4402 infuses insulin or glucagon into the user 4406. Theuser 4406 may transport the ambulatory medical device 4402. Thus, as theuser 4406 moves around, there is a danger that the user 4406 willinadvertently activate input in the ambulatory medical device 4402 thatinitiates a therapy change input 4410.

The therapy delivering component 4408 provides medicaments to the user4406. Signals received from the signal processing component 4404 areexecuted by the therapy delivering component 4408 to change therapy suchas starting, modifying, or stopping a therapy. The therapy deliveringcomponent 4408 may have a computing component for interpreting andexecuting instructions from the signal processing component 4404. Thus,the therapy delivering component 4408 can follow a program that iscontrolled by the signal processing component 4404. In one embodiment,the therapy delivering component 4408 is one or more infusion pumps. Aninfusion pump is capable of delivering fluids at varying rates to a user4406. The infusion pump may deliver any fluid, including medicaments.The infusion pump may be connected to a user 4406 through any means. Inone example, the infusion pump is connected to the body through acannula. In an exemplary embodiment, the therapy delivering component4408 is an insulin infusion pump. Also, in an exemplary embodiment, thetherapy delivering component 4408 is an insulin and glucagon infusionpump. Signals received from the signal processing component 4404 may beinterpreted by an insulin and glucagon pump to start, stop, or changethe rate of insulin and glucagon being delivered into a user 4406.

In an exemplary embodiment, the therapy delivering component 4408 is anelectrical stimulation device. An example of an electrical stimulationdevice is a cardiac pacemaker. A cardiac pacemaker stimulates thecardiac muscle to control heart rhythms. Instructions received from thesignal processing component 4404 may be interpreted by a cardiacpacemaker to start stimulating a cardiac muscle, stop stimulating acardiac muscle, or change the rate of stimulation of a cardiac muscle.Another example of an electrical stimulation device is a deep brainstimulator to treat Parkinson's disease or movement disorders.Instructions received from the signal processing component 4404 may beinterpreted by the deep brain stimulator to start, stop, or modify thestimulation of the brain.

The therapy change input 4410 is an input provided by the user 4406 tochange a therapy that is currently being delivered to the user 4406. Thechange of therapy may be to start a therapy, modify a therapy, or cancela therapy. There are many types of possible therapy changes, and thetypes of therapy changes are dependent on the type of ambulatory medicaldevice 4402. In one embodiment, the ambulatory medical device 4402 is aninsulin or glucagon infusion device. However, there are many possibleembodiments of ambulatory medical devices 4402 for the disclosed subjectmatter. The therapy change input 4410 in an insulin or glucagon infusiondevice may be an instruction, that when executed, causes the insulin orglucagon infusion device to start infusing an amount of insulin orglucagon into the user 4406. Alternatively, the therapy change input4410 may be an instruction to modify the rate of insulin or glucagoninfusion into the user 4406. The therapy change input 4410 may also bean instruction to cancel insulin or glucagon infusion into the user 4406from the insulin or glucagon infusion device. In an exemplaryembodiment, the ambulatory medical device 4402 is an electrical implant,that when operated, stimulates a part of the body. An example is anelectrical brain implant for users 4406 with Parkinson's disease or forpain management. The implementation of the therapy change can be tomodify the rate of electrical stimulation to the body.

The therapy change delivery 4416 is the performance, by the ambulatorymedical device 4402, of the therapy change input 4410 that was verifiedby the 4414. The therapy change that is delivered by the therapy changedelivery 4416 corresponds to the therapy change selection made by theuser 4406. In one embodiment, the ambulatory medical device 4402 alertsthe user 4406 that it is performing a therapy change delivery 4416. Inan example of various embodiments, the ambulatory medical device 4402displays the therapy change during the therapy change delivery 4416. Anynumber of details of the therapy change may be displayed during thetherapy change delivery 4416. As shown in FIG. 51, a simple message of“Delivering” may be displayed during the therapy change delivery 4416.Alternatively, more exact details, such as “Delivering 2 units ofinsulin” or “Delivering insulin at 2 units per minute” may be displayed.In another example, the ambulatory medical device 4402 plays a soundeffect during the therapy change delivery 4416. In an exemplaryembodiment that is shown in FIG. 51, the therapy change delivery 4416may be canceled by an input by the user 4406. The input to cancel atherapy change delivery 4416 may be any input such as a wake signalinput or a series of touch inputs such as a gesture.

The input components 4412 allow the user 4406 to interact with andcontrol the ambulatory medical device 4402. The amount of control that auser 4406 has may vary based on the type of ambulatory medical device4402 and the user 4406. For example, an ambulatory medical device 4402that delivers pain medication may allow the user more control than anambulatory medical device 4402 that controls heart rhythms. In anotherexample. a user 4406 that is a young child (less than about 10, 11 or 12years) may be allowed less control over an ambulatory medical device4402 than a user 4406 that is a teen or an adult. The input components4412 include a wake button 4426, a touchscreen display 4428, and analphanumeric pad 4430.

The wake button 4426 is activated by a user 4406 to create a wake signalinput to unlock an ambulatory medical device 4402. The wake button 4426may be any input button. In one embodiment, the wake button 4426 is acapacitive button that detects a change in capacitance. The wake button4426 may have a computing component for interpreting and executinginstructions from the signal processing component 4404. Thus, the wakebutton 4426 can follow a program that is dictated by the signalprocessing component 4404.

The touchscreen display 4428 may display a therapy change user interfacefor the user 4406 and receive user 4406 inputs on the touchscreendisplay 4428 input surface. Inputs on the touchscreen display 4428 maybe registered by any touch technology including, but not limited tocapacitive and resistive sensing. The touchscreen display 4428 may be apart of a mobile computing device, such as a cellular phone, tablet,laptop, computer or the like. The touchscreen display 4428 may have acomputing component for interpreting and executing instructions from thesignal processing component 4404. Thus, the touchscreen display 4428 canfollow instructions that are directed by the signal processing component4404. To receive input, the touchscreen display 4428 may displaybuttons, alphanumeric characters, symbols, graphical images, animations,or videos. The touchscreen display 4428 may display an image to indicatewhen the ambulatory medical device 4402 is locked or inaccessible viathe touchscreen display 4428. The touchscreen display may receive theseries of inputs that make up the first gesture and the second gesture.

The alphanumeric pad 4430 registers numerical inputs, alphabeticalinputs, and symbol inputs. The alphanumeric pad 4430 includes amultitude of keys corresponding to numerical, alphabetical, and symbolinputs. The alphanumeric pad 4430 may have a computing component forinterpreting and executing instructions from the signal processingcomponent 4404. Thus, the alphanumeric pad 4430 can follow instructionsthat are dictated by the signal processing component 4404. Thealphanumeric pad 4430 may be configured to provide haptic feedback fromits keys. The alphanumeric pad or pads 4430 may have any number of keysand any number of characters and may span multiple screens that the user4406 can toggle between in order to find all of their sought-aftercharacters. In one embodiment, the wake button 4426 is incorporated intothe alphanumeric pad 4430. In various embodiments, the wake button 4426may be any one or more keys of the alphanumeric pad 4430. In anexemplary embodiment, the alphanumeric pad 4430 is displayed as part ofthe touchscreen display 4428. Characters from the alphanumeric pad 4430may be used as input for the wake signal input, first gesture, therapychange selection, and second gesture. In an exemplary embodiment, thefirst gesture and/or second gesture are created by enteringpredetermined characters on the alphanumeric pad 4430.

The activity change component 4414 may be part of a specialized softwarethat is executed on an ambulatory medical device or include aspecialized hardware that performs the various functions described here.The activity change component 4414 may receive inputs from the userregarding weather the user is about to conduct activities that willchange the blood glucose of the user. For example, the user may provideinput using the input components 4412 that the user is about to performexercise that may lower their blood sugar or eat a meal that willincrease their blood sugar. Upon receiving the activity change from theinput components 4412, the activity change component 4414 offers theuser the option via the mode controller 4420 to select between theautomated delivery system 4418 or the manual delivery component 4422. Asshown in FIG. 44, the manual delivery system may inform the automateddelivery system 4418 and the model predictive control component 4424regarding any manual medicament deliveries of insulin or glucagon.

In various embodiments, the user may choose the dosage amount, the drugtype (insulin or glucagon; fast or slow acting) and the time of thedelivery and the manual delivery component 4422 may receive suchinformation and deliver the medicament(s) accordingly. In oneembodiment, the manual delivery component 4422 may inform the automateddelivery system 4418 and the model predictive control component 4424regarding the drug type (insulin or glucagon; fast or slow acting) andthe time of the delivery.

When the user activates the automated delivery system 4418, the datafrom previous manual medicament infusions can be readily available sothat the automated delivery system 4418 may be able to determine howmuch medicament is still in the user's blood stream. The automateddelivery system 4418 may make that determination by tracking the finiterate of utilization of infused insulin by the subject based on the timeand amount of any manual medicament infusions reported to the automateddelivery system 4418.

FIG. 45 is a flow chart of a process 4500 detailing a medicamentselection process, according to an exemplary embodiment. In step 4502,the medical device provides an option to a user to select betweenreceiving medicament using a manual delivery component or an automateddelivery system. By using the mode controller 113, the user can selectthe method for the therapy change request between manual deliverycomponent and the automated delivery system.

In step 4504, the medical device may receive subjective informationregarding the activity or action that may alter the blood-glucose level.Subjective information may include the size of the meal and/or the typeof physical activity. In step 4506, the manual delivery component mayreceive an amount of the medicament to be infused. The medicament may bea plurality of hormones, including but not limited to, glucagon orinsulin. At step 4508, the medical device may store a time and theamount of medicament that was infused into the automated deliverycomponent that controls the blood glucose level. The systems that aredisclosed in FIG. 44 will be utilized to accomplish each and every stepfrom steps 4502, 4504, 4506 and 4508.

FIG. 46 is another flow diagram of a process 4600 for providing optionsfor meal dosage selection or physical activity of the user on anambulatory device. Embodiments described herein include an ambulatorymedical device that has a keypad which allows a user to type in a doseof insulin or glucagon to be administered to a user. A user may wish toreceive a single dose of insulin prior to consuming food and decide howmuch insulin need to be administered. In other embodiments, the user maychoose to receive a burst of glucagon due to low blood sugar because ofphysical activities. Embodiments may include the options for manualinputs of medicament and automated delivery system of medicament. Invarious implementations, the automated delivery system of medicament isdriven by the blood glucose level or related trends. Embodiments hereinaddress a problem that may arise when the user has just received amanual dose and has switched on the automated delivery system. In suchcases, the automated delivery system may be made aware of all manualmedicament infusion amounts and the timing of such infusions.Accordingly, the manual delivery component may inform the automateddelivery system upon delivering any medicament the type of medicamentdelivered, the amount of medicament and the timing of the medicamentdelivered. By having the above information, the automated deliverysystem may determine the amount of medicament that is the user's bloodstream and adjust the automated delivery of medicament and the timing ofthe automated delivery. Accordingly, embodiments are directed to allowsfor a risk free transition from the manual delivery component and theautomated delivery system.

At block 4602, the user may inform the activity change component 4414that the user is about to engage in activities that may alter theblood-glucose level of the user. The mode controller 4420 may beactivated at decision block 4604 and ask whether the user wants to usethe manual delivery component 4606 or the automated system 4610. If theuser chooses to use the manual delivery component 4606 and the userprovides an input to infuse medicament, the ambulatory device 4402 maydelivery the medicament to the user. Upon the manual delivery processcompletion, the manual delivery component 4606 may inform at least oneof the model predictive control component 4608 and the automateddelivery system 4610 regarding the type of medicament, amount ofmedicament and the time when the medicament was delivery. The predictivecontrol component 4608 and automated delivery system 4610 may trackthese manual infusions of medicament and determine that based on therate of decay or the half-life of the medicament the total amount ofmedicament that remains in the user's blood stream at a particular timeor a period of time. Accordingly, when the automated delivery system4610 is activated by the user, the automated delivery system 4610 maychange its medicament infusion based on the medicament that remains inthe user's blood stream after a manual infusion by the user.

Differences from other system may include that the manual delivery maybe tied to an automated delivery system, the dose input from the user isthen stored into the MPC algorithm (Model Predictive Control) instead ofthe meal delivery algorithm and is handled by the MPC algorithm. Otherembodiments may include selection being able to have a relativisticalgorithmically tuned value. Other embodiments may include a learningalgorithm that includes a usual size meal or larger size meal or smallsize mean. Embodiments may include correlating the manual inputs toasking the user what was the size of the meal and learning how theinsulin affects the user. Embodiments may include correlating the manualinputs to asking the user what activity the user performed and learninghow the glucagon affects the user for a particular activity.

FIG. 47 illustrates a plurality of screens 4700 that may be produced bythe ambulatory medical device 102. The plurality of screens 4700demonstrates a process that a user may take in order to enter mealdoses. When the mode controller 4420 is activated, the enter meal dosesscreen 4702 may be displayed. Once the screen 4702 is displayed, awarning text may be displayed for the user to ensure safety. The warningtext states that entering a dose may be unsafe and the device will notadapt its meal doses. This warning text cautions the user of the risksthat may be involved in the process of using the ambulatory medicaldevice 4402. After a user acknowledges the warning sign and choses toproceed, a password screen 4704 may be displayed. Once the passwordscreen 4704 is displayed, a keypad is provided for the user to enter apredetermined sequence of numbers to ensure that the user is the actualregistered user of the ambulatory medical device 4402. When theambulatory medical device 4402 receives the correct predeterminedpassword from the user, the enter meal doses official screen 4706 andmeal doses official screen 4708 may be displayed. The user may decide toaccess the advanced screen 4712, and upon doing so, the advanced screen4712 will allow the user to double check the CGM Insulin levels andchange the speed of the of the insulin pump. In screen 4706 and screen4708, the user is provided the option to have the meal keypad on or off.If the user selects to have the keypad on, then an option may beprovided for the user to choose the max dose limit. If the user decidesto choose the max dose limit, the official max dose limit screen 4710 isdisplayed, where the user may enter up to 10 units of the dose. Theprovided number of units is then stored in the model predictive controlcomponent 116 for further regulation of the blood glucose level.

FIG. 48 illustrates a plurality of screens 4800 that may be produced bythe ambulatory medical device 4402. Upon activating the ambulatorymedical device 4402, the initial menu screen 4802 may be displayed. Inthe menu screen 4802, options regarding functionalities of theambulatory medical device 4402 is provided. The list of functionalitiesmay cover all the aspects of the ambulatory medical device 4402. Theuser may access and control many aspects of the device by choosing thesetting option. The setting option will allow the user to further assessand regulate the adjustable functionalities of the ambulatory medicaldevice 4402. Upon selecting the setting option, the setting screen 4804may be displayed and the user may select the advanced setting option.Upon selecting the advanced option, the advanced setting screen 4806 isdisplayed, and the user is provided the option to double check the CGMinsulin levels and change the speed of the of the insulin pump. The usermay speed up the process or slow down the process depending on theregulation stats that are provided by the model predictive controlcomponent 4424.

FIG. 49 illustrates a plurality of screens 4900 that may be produced bythe ambulatory medical device 4402. The plurality of screens 4900 is theprocess that a user may take in order to enter meal announcements. Thehome screen 4902 provides information and stats regarding the cartridgeof the ambulatory medical device 4402. The user may select the mealbutton with or without an installation of a new cartridge. If a userselects the meal button without installing a new cartridge, theambulatory device 4402 will display the warning screen 4906, where theuser is warned that the insulin cartridge is empty, and the devicefurther advises the user to change the cartridge. However, if a newcartridge is already installed and the food button is pressed, theambulatory medical device 4402 will display the carbs screen 4904, wherethe user is provided the option to choose a meal dose option. The carbsscreen 4904 allows the user to provide subjective information regardingthe food that is to be digested. This subjective data provided by theuser is further stored in the model predictive control component 4424for further regulation of the blood glucose level.

FIG. 50 illustrates a plurality of screens 5000 that may be produced bythe ambulatory medical device 4402. The plurality of screens 5000demonstrates the process of the user being alerted about the emptycartridge and having the option to replace the cartridge and furtherenter the meal doses. Warning screen 5002 alerts the user that theinsulin cartridge is empty and the fact that it needs to be replaced.Upon replacing the cartridge, screens 5004 and 5006 will be displayed.Screen 5004 is initially displayed, and a user may enter a specifieddose for each meal on a numerical pad. Upon inserting a numericalspecified dose, screen 5006 is displayed where a next button is providedfor the user to further complete the therapy change. The numericalspecified dose is further stored in the model predictive controlcomponent 4424 for further regulation of the blood glucose level.

FIG. 51 illustrates a plurality of screens 5100 that may be produced bythe ambulatory medical device 4402. Upon selecting the delivery request,a user may cancel the delivery of the medicaments prior to thecompletion of the delivery. The ambulatory medical device 4402 displaysa countdown prior to delivery. The initial countdown screen 5102 isproceeded by the secondary countdown screen 5106. During these countdownscreens, a cancel button is provided for the user to cancel the therapychange. During the initial countdown screen 5102 or the secondarycountdown screen 5106, the user may cancel the delivery at any time. Byswiping the cancel button, the user may officially stop the delivery ofthe therapy change. If the user does not cancel, the therapy change maybe delivered successfully. Furthermore, the time and the amount of thetherapy change delivery is stored in the model predictive controlcomponent 4424 for further regulation of the blood glucose level.However, if the user decides to cancel the delivery, the delivery willbe canceled and the screen 5104 will be provided. Once the deliverycancelation is requested and the screen 5104 is displayed, upon pressingthe ok button, the ambulatory medical device 4402 will display a lockscreen 5108 and take the time to officially cancel the therapy changerequest.

FIG. 52 is a block diagram illustrating a computer system 5200 that maybe implemented in the various embodiments in the described subjectmatter. The computer system 5200 includes a processor 5202, main memory5204, storage 5206, a bus 5208, and input 5210. The processor 5202 maybe one or more processors. The processor 5202 executes instructions thatare communicated to the processor through the main memory 5204. The mainmemory 5204 feeds instructions to the processor 5202. The main memory5204 is also connected to the bus 5208. The main memory 5204 maycommunicate with the other components of the computer system through thebus 5208. Instructions for the computer system 5200 are transmitted tothe main memory 5204 through the bus 5208. Those instructions may beexecuted by the processor 5202. Executed instructions may be passed backto the main memory 5204 to be disseminated to other components of thecomputer system 5200. The storage 5206 may hold large amounts of dataand retain that data while the computer system 5200 is unpowered. Thestorage 5206 is connected to the bus 5208 and can communicate data thatthe storage holds to the main memory 5204 through the bus 5208.

The processor 5202 may be any type of general purpose processorincluding, but not limited to a central processing unit (“CPU”), agraphics processing unit (“GPU”), a complex programmable logic device(“CPLD”), a field programmable gate array (“FPGA”), or anapplication-specific integrated circuit (“ASIC”). One embodiment of thecomputer system 5200 in the ambulatory medical device 102 features a CPUas the processor 5202. However, embodiments may be envisioned for thecomputer system of the ambulatory medical device 102 that incorporateother types of processors 5202.

The main memory 5204 can be any type of main memory that can communicateinstructions to the processor 5202 and receive executed instructionsfrom the processor 5202. Types of main memory 5204 include but are notlimited to random access memory (“RAM”) and read only memory (“ROM”). Inone embodiment, the computer system 5200 incorporates RAM as the form ofmain memory 5204 to communicate instructions to the processor 5202 andreceive executed instructions from the processor 5202. Other embodimentsmay be envisioned that incorporate other types of main memory 5204 inthe computer system 5200.

The storage 5206 can be any type of computer storage that can receivedata, store data, and transmit data to the main memory 5204 via the bus5208. Types of storage 5206 that can be used in the computer system 5200include, but are not limited to, magnetic disk memory, optical diskmemory, and flash memory. In one embodiment, flash memory is used as thestorage 5206 in the computer system 5200 of the ambulatory medicaldevice 102. Other embodiments that use other types of storage 5206 forthe computer system 5200 may be envisioned.

The bus 5208 connects the internal components of the computer system5200. The bus 5208 may include a multitude of wires that are connectedto the components of the computers system 5200. The wires of the bus5208 may differ based on the components of the computer system 5200 towhich the bus 5208 connects. In various embodiments, the bus 5208connects the processor 5202 to the main memory 5204. In variousembodiments, the processor 5202 is directly connected to the main memory5204.

The input 5210 of the computer system 5200 includes a touchscreendisplay 5212, an alphanumeric pad 5214, and buttons 5216. Thetouchscreen display 5212 both produces output and accepts input. The bus5208 may be coupled to the touchscreen display 5212 to produce visualoutput. The touchscreen display 5212 may also accept input viacapacitive touch, resistive touch, or other touch technology. The inputsurface of the touchscreen display 5212 can register the position oftouches on the surface. Some types of touchscreen display 5212 canregister multiple touches at once. The alphanumeric pad 5214 includes amultitude of keys with numerical, alphabetical, and symbol characters.Signals from the alphanumeric pad 5214 are communicated by the bus 5208to the main memory 5204. Keys of the alphanumeric pad 5214 may becapacitive or mechanical. In some embodiments, the alphanumeric pad 5214is displayed on the touchscreen display 5212. Buttons 5216, such as thewake button 120, may be capacitive, mechanical, or other types of inputbuttons.

Control Systems for Managing State Data

Glucose control therapy, such as blood glucose control therapy,generally requires the coordination of many elements within a system.For example, a glucose control therapy system can broadly include one ormore medicament delivery systems (e.g., a medicament pump, a patch pump,a medicament pen, a hospital infusion pump), a control system, and/or aglucose sensor (e.g., a continuous glucose monitor (CGM)). Each of thoseelements may include one or more sub-elements. In order for data, suchas state data, to be properly managed among the various elements of thesystem, the various elements must be able to properly communicate withone another. For example, a system involving a plurality of medicamentpumps (e.g., ambulatory medicament pumps) must be able to provide propercommunication among the various devices and properly store and managethe relevant data. This need to properly manage the relevant state data,such as historical state data, often demands that the data be properlyreceived, stored, and/or transmitted at appropriate times and in anappropriate manner. Modern systems do not generally allow for properdata management that satisfy these needs. However, systems and methodsdescribed herein help solve this deficiency in the art.

Running an AID (Automated Insulin Dosing) algorithm often requires themanagement of state data, such as insulin on board (IOB), learned basalrates, meal sizes, aggressiveness factors, etc. Since these data canoften take several days to learn and refine, it is beneficial to be ableto transfer these data to a new pump when changing out a disposablepump.

The state data is generally precious and/or private and so shouldgenerally be stored in a location and manner to be safely transferred toa new pump. The state data can be stored on the original pump, a mobiledevice and/or a remote server. As described in more detail below, thepump and/or control system can use near-field communication (NFC) oranother wireless interface to transfer data from the old pump to a newpump. Such transfers may not even require power to successfully occur.For example, writeable NFC tags may be written-to without power of theirown, using energy received via the NFC signal. In some cases, anNFC-enabled fob may be swappable and may not need a power source.

During a pump transition, the state data may be transferred from astorage media to the new pump. State data can include a variety of datadescribed herein, such as a latest dosing history, an amount of IOB,recent CGM history, recent meal announcements, algorithm-specificcontrol parameters (see above related to the PK model), pump settings,dose-related parameters, alarm history, alarm acknowledgement status,user preferences, estimated correction factors and carb ratios, basalrates, meal dose sizes, and physiological model state (subject model).

The user interface for these connections may be such that when the newpump is paired, the state data is transmitted and the communication ismonitored for errors. If errors are detected, one or more retries can beattempted. If these fail, the state data may be reset to a safe state.

Managing and storing the data as described herein may involve advanceddata security and integrity protocols. For example, during transmissionof data between devices, the data may be encrypted. The transmittingand/or receiving device may execute one or more cyclic redundancy checks(CRCs), which may include repeatable calculations to better confirm thatdata is not corrupted during transmission. Additionally oralternatively, a private/public key system may be employed. The publickey may be used to transfer data, and each receiving device (e.g.,control system, medicament pump, remote computing environment, etc.) mayhave a private key for encryption/decryption. Additionally oralternatively, a digital signature may be required for successfultransmission. Each medicament pump can include a key pair. A remoteelectronic device (e.g., a remote computing environment) can hold aregistry of public keys to confirm that data transfer is going to thetarget receiving device.

In some embodiments, the medicament device can be manufactured with adigital certificate that confirms that the medicament device iscertified by the manufacturer and has the correct key pair. The digitalcertificate can include a signed public key and/or private key thatexists in a secured enclave (e.g., in a remote computing environment).The digital certificate may be passed from an old medicament device to anew (replacement) medicament device to confirm that the medicamentdevices are properly certified.

As described below, a control system may be configured to connect to oneor more medicament pumps. Each medicament pump may be assigned aspecific user account. For example, a medicament pump can already belinked to a user when the medicament pumps is shipped by themanufacturer to the user. Additionally or alternatively, the useraccount can be associated between the user and the medicament pumpduring a pairing process. Unique identifiers may be stored on thecontrol system so that a user may indicate her/his identity via avariety of methods, such as using a biometric identifier (e.g.,fingerprint, retina scan) or a digital key identifier (e.g.,username/pas sword).

Although any medicament delivery system may be used in the systems andmethods described herein, for convenience reference will be made to amedicament pump below. A modular control system can providecommunication among a plurality of medicament pumps and/or a glucosesensor.

One way to allow interoperability among a plurality of medicament pumpsis to use a control system that manages the storage and/or flow of dataamong the medicament pumps. In some examples, a first medicament pump isconfigured to store data therein (e.g., in non-transitory memory, on aremovable data module, etc.) and to allow transmission of that data to asecond medicament pump.

The control system may be configured to be operated on a separate devicefrom the plurality of medicament pumps. Additionally or alternatively,the control system can be self-contained within a small modularcomponent, such as within a chip, of a medicament pump. The system cancomprise a system on a module (SOM), which can allow the module to bedisposed within a number of medical devices, such as a medicament pump(e.g., an ambulatory medicament pump) or other medical device. Thecontrol system can include a data interface to communicate with otherelectronic devices, such as a remote network (e.g., cloud, server), oneor more medicament pumps, a glucose sensor, and/or a computing device(e.g., a laptop, cell phone, smartphone, Personal Diabetes Manager(PDM), tablet, wearable electronic device, etc.). The data interface caninclude a wired data interface and/or a wireless data interface. Thedata interface may refer to a plurality of data interfaces. In someexamples, each data interface of the plurality of data interfaces isconfigured to communicate with a different electronic device.

In some examples, the control system can include one or more algorithmsstored thereon, such as the control algorithm described above. Thesystem may be able to output a dosing recommendation to a pumpcontroller via a wired and/or wireless data interface. The system canintegrate cellular wireless and/or GPS radio module(s) as well. Thedosing recommendation can include a command or instruction to the pumpcontroller. Additionally or alternatively the recommendation may includea displayed recommendation but no command for some reason (e.g., thatthe medicament pump or a component thereof), and feedback can beaccepted (e.g., in case the user performs a manual injection).

The control system can receive historical pump data from a firstmedicament pump and decode encoded data of the historical pump data toobtain therapy data associated with the delivery of the glucose controltherapy (e.g., an amount of a medicament delivery, a time of themedicament delivery) and/or one or more glucose control parameters. Theone or more glucose control parameters can include a variety ofparameters. Example of glucose control parameters include an insulindecay rate constant associated with a decay rate of insulin at asubcutaneous depot of the subject, a clearance time associated with anestimate of an amount of time for a bolus of insulin to be utilized bythe subject, an insulin rise rate constant associated with a rise rateof insulin in blood of the subject after a bolus of insulin, a half-lifevalue associated with when a concentration of insulin in blood plasma ofthe subject reaches half of a maximum concentration in the blood plasma,a weight of the subject, an age of the subject, demographic informationassociated with the subject, a sensitivity constant (e.g., an indicationof a date of diagnosis, which may indicate a newly diagnosed diabetic)associated with the subject's sensitivity to a glucose level or bolus ofmedicament, a health state the subject (e.g., subject is pregnant orsick), an activity level of subject, a diet of the subject, a basal rateof medicament delivery associated with the subject, a correction factor,a carbohydrate ratio, a glucagon control parameter, and/or any otherparameter described herein.

The control system can determine that at least one of a plurality ofpairing conditions is satisfied to connect the data interface to thesecond medicament pump. Example pairing conditions include a userrequest to pair the control system to a second medicament pump, a userinput initiating a replacement process for a first medicament pump, anindication that the second medicament pump is operatively connected todeliver medicament to the subject, a sensory alarm configured to alert auser that stored historical pump data is ready for transmission, analert indicating a malfunction associated with the first medicamentpump, a determination that a level of medicament in a medicamentreservoir of the first medicament pump is below a threshold level, asignal received from a remote electronic device (e.g., a remote server,a user device) requesting transmission of the stored data, and/or anyother pairing condition described herein.

The control system can transmit a pairing signal to the secondmedicament pump. In some embodiments, the control system receives aconfirmation signal from the second medicament pump. The may transmit,in response to receiving the confirmation signal, the stored data. Insome examples, the control system can estimate one or more glucosecontrol parameters based on stored data, such as therapy data associatedwith the delivery of the glucose control therapy. In some embodiments,the control system can receive a glucose level signal from a glucosesensor operatively coupled to the subject and estimate one or moreglucose control parameters based on the glucose level signal receivedfrom the glucose sensor. The control system can include a graphical userinterface and may transmit to the graphical interface the stored data.In some examples, the control system can transmit the stored data to aremote electronic device, such as a mobile device, a remote computingenvironment, or some other remote device.

In some embodiments, the control system can receive data from the firstmedicament pump, such as an therapy data associated with the delivery ofthe glucose control therapy, one or more glucose control parameters, andor any other state data.

The control system can include one or more computing components,including a microprocessor, a Bluetooth Low Energy (BLE) wireless modem,a clock, and/or non-volatile memory to independently operate andmaintain a wireless connection and/or calculate dosing results. Asdescribed in more detail below, the system can save and restore statedata and/or other data on the module. Additionally or alternatively, thesystem can receive remote software upgrade services and provide them toa target pump controller or other associated medical device. Because ofthe benefits of the system where applicable (e.g., interconnectivityamong medicament pumps, a small form factor, etc.), the system can bepart of a digital infrastructure that provides interactivity amongmultiple electronic devices, such as a mobile device, wearable device(e.g., smart watch), cloud network, and/or third-party services. Thesystem may include a hardware and/or software validation package thatsatisfies public standards, such as, for example, FCC, EMC/EMI, IEC62304, or other validation standard. In some examples, the system can becoupled directly to an infusion pump, such as a pump in a hospital room.

The control system may receive one or more inputs from a user and/orfrom another device. For example, the system may receive one or moreglucose control parameters or other state data from the user. These datamay be received via a graphical user interface or other user controlelement coupled to the control system.

The modular system can receive various details related to a subjectreceiving therapy. For example, the system may receive a body weightand/or glucose control parameters from a remote device and/or from adirectly coupled medical device. In some embodiments, the modular systemcan receive meal announcement requests and/or a pump status.

The control system can receive indications of the status of a pumpcontroller of one or more medicament pumps. For example, the modularsystem can receive an indication that the pump controller of a firstmedicament pump is available and/or that it is not available fordelivery of therapy. In some embodiments, the modular system may receivea delivery report. The delivery report may indicate how much therapy wasdelivered since a previous time (e.g., since a most recent statusrequest) or how much therapy was delivered at some historical point. Thedelivery report can include a recommendation for future therapy. Therecommendation may include a command to deliver the recommended therapy.

The control system may determine one or more glucose control parametersby learning the glucose control parameters during online operation of anautomated glucose control system. For example, the modular system maygenerate the glucose control parameters by calculating a size of acorrection bolus of insulin of the regular correction boluses at a timeof receiving an isolated glucose measurement (e.g., from a glucosesensor). Additionally or alternatively, the system may generate theglucose control parameters by calculating a size of a meal bolus ofinsulin. The glucose control parameters may be determined by use of thecontrol algorithm described above.

The control system can receive historical pump data from one or moreambulatory medicament pumps. The historical pump data can includeencoded data. For example, the historical pump data can include encodeddata corresponding to therapy data (e.g., glucose control therapy data)associated with delivery of glucose control therapy delivered by anambulatory medicament pump to the subject. The therapy data can includeone or more of an amount of insulin on board, a value used in apharmacokinetic (PK) model of a control algorithm, a time of a deliveryof medicament, an amount of delivery of medicament, and/or anotherparameter associated with therapy delivery. In some examples, thetherapy data includes version data. The version data can include atimestamp corresponding to a time associated with an update of thetherapy data. For example the timestamp can indicate when the lastrecorded delivery of therapy occurred. Additionally or alternatively,the version data may include an indicator of an ordering within asequence of delivery of the glucose control therapy. For example, theversion data may indicate where in the sequence a particular delivery oftherapy occurred. The version data may include a version code comprisingencoded time data associated with delivery of the glucose controltherapy. The version code may be encoded to identify a time of day ofdelivery of medicament, a time within a session of multiple deliveriesof medicament, an ordering within the session, or some other indicatorof when therapy was delivered.

Additionally or alternatively, the historical pump data can includesecond encoded data corresponding to one or more glucose controlparameters used by an ambulatory medicament pump in calculating a dosecontrol signal. There are many examples of glucose control parameters. Anon-exhaustive list of such glucose control parameters includes, but isnot limited to: an insulin decay rate constant associated with a decayrate of insulin at a subcutaneous depot of the subject, a clearance timeassociated with an estimate of an amount of time for a bolus of insulinto be utilized by the subject, an insulin rise rate constant associatedwith a rise rate of insulin in blood of the subject after a bolus ofinsulin, a half-life value associated with when a concentration ofinsulin in blood plasma of the subject reaches half of a maximumconcentration in the blood plasma, a weight of the subject, an age ofthe subject, a learned parameter (e.g., via a control algorithmdescribed herein, such as a learned basal rate), glucose level data ofthe subject, a model parameter associated with a pharmacokinetic (PK)model, a health state of the subject (e.g., sick, pregnant, etc.), aparameter associated with an activity level of the subject, an aspect ofa diet of the subject (e.g., smoker), a basal rate of insulin deliveredto the subject, a correction factor, a carbohydrate ratio associatedwith the subject, a glucagon control parameter, demographic informationassociated with the subject, a sensitivity constant (e.g., date ofdiagnosis) associated with the subject's sensitivity to a glucose levelor bolus of medicament, or any other parameter that may be used incalculating a dose control signal, such as those described herein.

The control system can decode the encoded data of the historical pumpdata to obtain the corresponding decoded data. These data may betransmitted to and/or stored in a memory of the control system.

It can be advantageous to maintain continuity of glucose control therapyto a subject, especially when changing pumps. Thus, the control systemcan be configured to be paired with a plurality of medicament pumps andto receive, store, and/or transmit glucose control therapy data to/fromone or more of the medicament pumps. Thus, the control system candetermine when a pairing with a medicament pump is initiated. Thecontrol system can determine that at least one of a plurality of pairingconditions is satisfied to connect the control system to a medicamentpump. For example, the control system may pair with a new/replacementpump so that the control system can transmit stored glucose controltherapy data to the replacement pump. A variety of pairing conditionscan exist. A non-exclusive list of example pairing conditions includes,but is not limited to, a user request to pair the control system to themedicament pump (e.g., to the replacement medicament pump), a user inputinitiating a replacement process for a medicament pump (e.g., an oldmedicament pump to be replaced), an indication that the medicament pump(e.g., the replacement medicament pump) is ready to deliver medicamentto the subject, a sensory alarm configured to alert a user that thehistorical pump data is ready for transmission, an alert indicating amalfunction (e.g., an occlusion, a low battery power, an electricalmalfunction, a controller malfunction, a pump malfunction) associatedwith the medicament pump, a determination that a level of medicament ina medicament reservoir of the medicament pump is below a thresholdlevel, a signal received from a remote electronic device requestingtransmission of at least one of the therapy data associated with thedelivery of the glucose control therapy or a glucose control parameter,or any other pairing condition.

In response to determining that the pairing condition is satisfied, thecontrol system can transmit a pairing signal to the medicament pump. Insome examples, the control system can receive a confirmation signal fromthe medicament pump. Additionally or alternatively, the control systemmay transmit the therapy data and/or the one or more glucose controlparameters in response to receiving the confirmation signal. The controlsystem may turn off a ready state of a medicament pump (e.g., themedicament pump to be replaced) in response to receiving theconfirmation signal. Turning off a ready state can include discontinuingthe control algorithm (described herein) on the medicament pump.

In some examples, the control system generates a dose control signalthat causes a pump controller of one or more medicament pumps to deliverthe medicament to the subject. For example, the control system maygenerate a dose control signal in the old/original medicament pump andin the replacement pump. The dose control signal may be based on one ormore factors, such as the therapy data associated with the delivery ofthe glucose control therapy and/or one or more glucose controlparameters. Generating the dose control signal may include calculatingregular correction boluses of glucose control agent, e.g., in responseto the one or more glucose control parameters.

The control system may further receive and be configured to decode otherencoded data, such as data corresponding to a glucose level of asubject. Additionally or alternatively, the control system can receiveand decode data corresponding to an indication of a glucose trend. Theglucose trend may indicate a predicted change in the glucose level ofthe subject.

In some embodiments, the control system can estimate current data basedon the historical data. The estimated data may not be exact but may beuseful in approximating glucose control therapy data to avoidsignificant lapses in therapy, such as between switching from an oldmedicament pump and a replacement pump. The control system can estimatethe glucose control parameter based on at least one of an amount ofglucose control therapy, a time of the glucose control therapy, and/oran amount of insulin on board. These estimated data may be slightlyinaccurate data based on historical data, but they may rely on one ormore of a trend and/or a snapshot in a subject's glucose control therapythat has been measured. For example, previously obtained historical datamay show a higher amount of insulin on board at a first time than at asecond time. This may indicate that the subject has received additionaltherapy between the first and second times. As another example, ameasured glucose level at a first time may have been higher than at asecond time, which may indicate that an amount of insulin on board maybe higher at the second time than at the first time. The actual (e.g.,measured) data may be transmitted to and/or stored by the controlsystem, which can use the actual data to make the estimation. The datamay be received from a medicament pump, from a glucose sensor (e.g., acontinuous glucose monitor (CGM)), and/or from another remote electronicdevice (e.g., a remote computing environment).

The control system may be configured to transmit various data to agraphical user interface. The control system may include the graphicaluser interface or the graphical user interface may be operativelycoupled to the control system. The control system can transmit the datato a remote electronic device, such as a medicament pump, a user device,and/or a remote computing environment.

It may be advantageous for the control system to periodically connectwith a medicament pump to obtain the therapy data. Because of physicalor electronic restrictions in the medicament pump (e.g., short batterylife, limited processing power, limited memory, etc.), it may not bepractical to be in continuous communication with the medicament pump,such as a pump that is to be replaced soon. In some embodiments, thecontrol system can connect with a medicament pump in response tosatisfaction of a data retrieval condition. The control system candetermine that at least one of a plurality of data retrieval conditionsis satisfied. If the data retrieval condition is satisfied, the controlsystem may connect to the medicament pump to connect the data interfaceto the medicament pump. In response to determining that the at least oneof a plurality of data retrieval conditions is satisfied, the controlsystem can receive the therapy data and/or the glucose controlparameter.

There are a variety of data retrieval conditions that can be satisfied.Generally, the data retrieval condition indicates a practical and/orconvenient time for which data may be transmitted to/from the controlsystem. A non-exhaustive list of such conditions includes, but is notlimited to, an occurrence of a scheduled time, a transmission of a mealannouncement (e.g., input by a user), a user request to pair the systemto the first ambulatory medicament pump, a user input initiating areplacement process for the first ambulatory medicament pump, anindication that the medicament pump is to be replaced, an indicationthat another medicament pump is ready to deliver medicament to thesubject (e.g., is operatively connected to the subject), a sensory alarmconfigured to alert a user that the historical pump data is ready fortransmission, an alert indicating a malfunction associated with themedicament pump, a determination that a level of medicament in amedicament reservoir of the first ambulatory medicament pump is below athreshold level, a determination that an amount of available medicamentof the first ambulatory medicament pump is insufficient for a subject'smedicament needs, a signal received from a remote electronic devicerequesting transmission of at least one of the therapy data or theglucose control parameter, and/or any other data retrieval condition.Reference will now be made to some of the figures.

FIG. 53 shows an example control system 5300 configured to transferhistorical pump data from a first ambulatory medicament pump to a secondambulatory medicament pump. The control system 5300 includes anon-transitory memory 5302, an electronic hardware processor 5304, and adata interface 5306. The data interface 5306 may include a wirelessand/or wired data interface. The data interface 5306 can include ashort-range wireless data interface.

The data interface 5306 may be in communication (e.g., wired, wireless)with one or more of a medicament pump 5308 (e.g., via a medicament pumpconnection 5318), with a network 5312 (e.g., via a network connection5320), and/or a user device connection 5322 (e.g., via a user deviceconnection 5322). Each of the connections 5318, 5320, 5322 may beone-way or two-way. The data interface 5306 may also be in communicationwith other elements of the medicament pump 5308, such as the pumpmechanism 5310 and/or the pump controller 5314. The communication withthe other elements of the medicament pump 5308 may be via a wiredconnection. The control system 5300 can represent one or a plurality ofmedicament pumps. In some embodiments, for example, the control system5300 is in communication with a medicament pump that is to be replacedas well as an additional pump to replace that pump. However, forsimplicity, reference to the medicament pump 5308 will represent one ora plurality of medicament pumps.

The medicament pump 5308 may be any medicament pump described herein,such as the pump 100 and/or pump 212. The pump controller 5314 isconfigured to direct medicament from a medicament reservoir to thesubject using the pump mechanism 5310.

The data interface 5306 may be able to communicate (e.g., wirelessly,via wired connection) with a medicament pump 5308, a network 5312,and/or a user device 5316 via respective connections 5318, 5320, 5322.The data interface 5306 can communicate with the medicament pump 5308,such as via a wireless connection. The medicament pump 5308 can includea pump mechanism 5310 and a pump controller 5314. In some embodiments,the data interface 5306 communicates with the pump controller 5314 ofthe medicament pump 5308.

The network 5312 may include any wired network, wireless network, orcombination thereof. For example, the network 5312 may be a personalarea network, local area network, wide area network, over-the-airbroadcast network (e.g., for radio or television), cable network,satellite network, cellular telephone network, or combination thereof.As a further example, the network 5312 may be a publicly accessiblenetwork of linked networks, possibly operated by various distinctparties, such as the Internet. In some implementations, the network 5312may be a private or semi-private network, such as a corporate oruniversity intranet. The network 5312 may include one or more wirelessnetworks, such as a Global System for Mobile Communications (GSM)network, a Code Division Multiple Access (CDMA) network, a Long TermEvolution (LTE) network, or any other type of wireless network. Thenetwork 5312 can use protocols and components for communicating via theInternet or any of the other aforementioned types of networks. Forexample, the protocols used by the network 5312 may include HypertextTransfer Protocol (HTTP), HTTP Secure (HTTPS), Message Queue TelemetryTransport (MQTT), Constrained Application Protocol (CoAP), and the like.Protocols and components for communicating via the Internet or any ofthe other aforementioned types of communication networks are well knownto those skilled in the art and, thus, are not described in more detailherein. The network 5312 may comprise the “cloud.” The network 5312 mayinclude a remote computing environment.

Various example user devices 5316 are shown in FIG. 53, including adesktop computer, a laptop, and a mobile phone, each provided by way ofillustration. In general, the user devices 5316 can be any computingdevice such as a desktop, laptop or tablet computer, personal computer,tablet computer, wearable computer, server, personal digital assistant(PDA), PDM, hybrid PDA/mobile phone, mobile phone, smartphone, set topbox, voice command device, digital media player, and the like. A userdevice 5316 may execute an application (e.g., a browser, a stand-aloneapplication) that allows a user to access and interact with interactivegraphical user interfaces as described herein.

The control system 5300 may be configured to store a plurality of pumpcontroller decoding profiles corresponding to respective pumpcontrollers. The control system 5300 can be configured to select a pumpcontroller decoding profile from a plurality of pump controller decodingprofiles. The pump controller profile can be configured to operate witha particular pump, with a brand of pump, and/or with a differentgrouping of pump.

The control system 5300 can be configured to determine a status of themedicament pump 5308, such as a status of the pump controller 5314. Thecontrol system 5300 can receive, via the data interface 5306, an encodedpump status signal from the pump controller 5314. The encoded pumpstatus signal can include data corresponding to an availability of theambulatory medicament pump to deliver medicament to the subject. Forexample, the pump status signal can indicate that the medicament pump5308 is ready to deliver glucose control therapy to a subject (e.g.,that the medicament pump 5308 is operatively connected to the subject).The control system 5300 can additionally or alternatively receive anencoded medicament delivery signal from the pump controller pumpcontroller 5314. The encoded medicament delivery signal can include datacorresponding to an amount of medicament dosed to the subject.

Each pump controller decoding profile can be configured to decodevarious data from the medicament pump 5308. For example, the decodingprofile can be configured to decode an encoded pump status signal, anencoded medicament delivery signal, encoded therapy data (e.g., glucosecontrol therapy data), encoded glucose control parameter data, anencoded glucose level of the subject, encoded data indicating a glucosetrend, and/or other encoded data. The glucose trend can indicate apredicted change in the glucose level of the subject over a time periodand/or at a given time. The encoded therapy data can contain therapydata, such as described herein. The glucose control parameter data caninclude one or more glucose control parameters, which may include anyglucose control parameter described herein. The selected pump controllerdecoding profile can correspond to the pump controller 5314 that isoperatively coupled to the medicament pump 5308. Using the selected pumpcontroller decoding profile(s), the control system 5300 can decode thecorresponding encoded data. In some embodiments, the control system 5300can calculate the dose control signal using a control algorithm(described above) that is configured to calculate regular correctionboluses of glucose control agent in response to at least the glucoselevel of the subject.

In some embodiments, in order to properly transmit the decoded data tothe pump controller 5314 (e.g., for instructions on delivering glucosecontrol therapy) of the corresponding medicament pump 5308, the controlsystem 5300 can proceed to encode the data so that it can be read by thecorresponding pump controller 5314. Note that the control system 5300may receive encoded data from a first medicament pump and may transmitencoded data to a second medicament pump. Like with the pump controllerdecoding profiles, the control system 5300 may have stored thereon oneor more of a plurality of pump controller encoding profiles. The controlsystem 5300 can select a pump controller encoding profile from theplurality of pump controller encoding profiles. The selected pumpcontroller encoding profile can correspond to the respective pumpcontroller 5314. The pump controller encoding profile can be configuredto encode the therapy data, the glucose control parameter data, the dosecontrol signal, and/or any other data that may be transmitted to thepump controller 5314.

The control system 5300 may determine that the medicament pump 5308 isready to deliver medicament to the subject. In some embodiments, thecontrol system 5300 can encode a dose control signal for commanding themedicament pump 5308 to administer glucose control therapy (e.g., usingthe pump mechanism 5310) via infusion of glucose control agent into thesubject.

The control system 5300 may be configured to communicate with aplurality of pump controllers, store and transmit historical data storedon the control system 5300 (e.g., in the memory 5302) in response to atriggering condition. In this way, the data may not be lost and can bepreserved for another medicament pump 5308. For example, a firstmedicament pump may be disposed of or intended to be disposed orreplaced, and a user or other individual may be interested in the storedhistorical data in the control system 5300. The historical data may bedata received from the first medicament pump, from the network 5312,from the user device 5316, from a glucose sensor, and/or from anotherelectronic device. Such historical data can include a therapy deliveryhistory, one or more glucose control parameters, and/or other data thatmay be stored over time on the control system 5300. In some embodiments,the control system 5300 can calculate a dose control signal for use inthe medicament pump 5308. Over time, the generated dose controlsignal(s) may be stored on the control system 5300. Additionally oralternatively, the control system 5300 may receive periodic and/orregular updated data from the medicament pump 5308 or other electronicdevice. These data may include therapy data or other state data and maybe stored in the memory 5302.

Once stored, the control system 5300 may be configured to transmit thestored data to a remote electronic device (e.g., a glucose sensor (notshown), the network 5312, the user device 5316) once a triggeringcondition is satisfied. The triggering condition can include one or moreof a variety of triggering conditions. These conditions may indicate orreflect a change that is occurring on the medicament pump 5308 and/or onthe control system 5300. The triggering condition may include a pairingcondition. For example, the pairing condition may include a user requestto pair the control system to the medicament pump 5308 (e.g., areplacement medicament pump 5308), a user input initiating a replacementprocess for the medicament pump 5308 (e.g., the pump to be replaced),and/or an indication that the medicament pump 5308 is ready to delivermedicament to the subject. Additionally or alternatively, the pairingcondition can include a sensory alarm configured to alert a user thatthe historical pump data is ready for transmission. The sensory alarmmay prompt a user to cause the control system 5300 to transmit the datato the remote electronic device. The pairing condition can include analert indicating a malfunction associated with the first ambulatorymedicament pump 5308. The malfunction may include any problem with themedicament pump 5308, such as a problem that may raise a potentialconcern of the ability of the medicament pump 5308 to properly delivermedicament. The malfunction can include, for example, an occlusion, alow battery power, an electrical malfunction, a controller malfunction,a pump malfunction, and/or any other malfunction in the proper operationof the medicament pump 5308.

It may be advantageous to bring to a user's attention that a medicamentpump 5308 is predicted not to be able to deliver adequate medicament tothe subject. For example, a user may want to replace the medicament pump5308 in such conditions. Accordingly, the pairing condition may includea determination that a level of medicament in a medicament reservoir ofthe first ambulatory medicament pump 5308 is below a threshold level, asignal received from a remote electronic device requesting transmissionof stored data, and/or any other indication that attention should bedrawn to the medicament delivery capability of the medicament pump 5308.The medicament reservoir may be included in the medicament pump 5308(not shown in FIG. 53). Other pairing or triggering conditions arepossible and these are listed by way of illustration only.

In embodiments where the pairing condition includes a sensory alarm, thesensory alarm may be configured to regularly and/or periodically alertthe user and/or subject until the glucose control parameters aretransferred to the remote electronic device (e.g., to the replacementmedicament pump). For example, the sensory alarm can include a visual,audible, haptic, and/or other alarm. in some embodiments, the sensoryalarm includes a beep, a tone, and/or other audible alarm. The alarm mayinclude a vibration and/or flashing light. The sensory alarm may beconfigured to be annoying to a user so that the user is motivated toprovide instructions for the control system 5300 to send the stored datato the remote electronic device.

The control system 5300 may monitor the data transfer for errors. If anerror is detected, the control system 5300 may automatically or manuallyattempt to retransfer the data. If the number of failed attempts exceedsa threshold number (e.g., 2, 3, 4, 5, 6), the state data may be reset toa safe state. In the safe state, the data may be restricted (e.g., canonly be transferred via a wired connection, requires special credentialsto request further transfer, etc.). The safe state data may be valuablebecause it describe the latest reliable state data even if it does notdescribe the latest state data stored on the control system 5300 and/oron the medicament pump 5308.

In some embodiments, the control system 5300 can transmit via the datainterface 5306 data to a graphical user interface. For example, thecontrol system 5300 may transmit a glucose level of the subject, glucosecontrol therapy data (e.g., a time and/or amount of deliveredmedicament), one or more glucose control parameters, an indication ofthe glucose trend of the subject, and/or other similar data to thegraphical user interface for display. Additionally or alternatively, thedata may be transmitted to a remote device, such as a user device 5316and/or the network 5312, via a corresponding connection 5320, 5322.

As noted above, the control system 5300 can receive, store, and/ortransmit one or more glucose control parameters to the one or moredevices illustrated, such as the medicament pump 5308 (e.g., themedicament pump to be replaced, a replacement medicament pump), the userdevice 5316, and/or the network 5312. As described above, exampleglucose control parameters can include a variety of parameters. Anon-exhaustive list of such glucose control parameters includes, but isnot limited to: an insulin decay rate constant associated with a decayrate of insulin at a subcutaneous depot of the subject, a clearance timeassociated with an estimate of an amount of time for a bolus of insulinto be utilized by the subject, an insulin rise rate constant associatedwith a rise rate of insulin in blood of the subject after a bolus ofinsulin, a value (e.g., half-life value) associated with when aconcentration of insulin in blood plasma of the subject reaches athreshold concentration (e.g., half, maximum) in the blood plasma, aweight of the subject, an age of the subject, a learned parameter (e.g.,via a control algorithm described herein), glucose level data of thesubject, a model parameter associated with a pharmacokinetic (PK) model,a health state of the subject (e.g., sick, pregnant, etc.), a parameterassociated with an activity level of the subject, an aspect of a diet ofthe subject (e.g., smoker), a basal rate of insulin delivered to thesubject, a correction factor, a carbohydrate ratio associated with thesubject, a glucagon control parameter, demographic informationassociated with the subject, a sensitivity constant associated with thesubject's sensitivity to a glucose level or bolus of medicament, or anyother parameter that may be used in calculating a dose control signal,such as those described herein. Other parameters may be included, suchas those with reference to the control algorithm above.

The control system 5300 can receive various data related to an amount ofinsulin on board and/or a value used in a pharmacokinetic (PK) model ofthe control algorithm described above. The control system 5300 may beconfigured to execute the control algorithm in some embodiments. Theglucose control therapy data may include the amount of insulin on boardand/or the value used in the PK model.

FIG. 54 shows a flow diagram illustrating an example method 5400 thatmay be used by a control system (e.g., the control system 5300) totransfer historical pump data from a first ambulatory medicament pump toa second ambulatory medicament pump. The system can receive thehistorical pump data comprising first and second encoded data from thefirst ambulatory medicament pump at block 5402. At block 5404 the systemdecodes (e.g., automatically) first and second encoded data of theglucose level signal to obtain therapy data and a glucose controlparameter. The glucose control parameter can include one or more of theglucose control parameters described above. At block 5406, the systemdetermines that at least one of a plurality of pairing conditions issatisfied to connect to a second ambulatory medicament pump. The pairingconditions may be any of the pairing conditions described herein. Atblock 5408, the system transmits a pairing signal to the secondambulatory medicament pump. At block 5410 the system receives aconfirmation signal from the second ambulatory medicament pump. At block5412, the system transmits, based on the confirmation signal, thetherapy data or the glucose control parameter to an electronic device,such as the second ambulatory medicament pump. In some embodiments, thesystem transmits the data additionally or alternatively to a remoteelectronic device, such as a remote server. In some embodiments, themethod 5400 includes turning off a ready state of the first ambulatorymedicament pump in response to receiving the confirmation signal.Turning off a ready state can include discontinuing running or executingan algorithm (e.g., a control algorithm described herein) on the targetmedicament pump.

In some embodiments, the method 5400 can include additional steps. Forexample, the system may generate, based on at least the therapy data andthe glucose control parameter, a dose control signal that is configuredto cause a pump controller of the first ambulatory medicament pump todeliver the medicament to the subject. The method 5400 may furtherinclude receiving additional encoded data corresponding to a glucoselevel of a subject and to an indication of a glucose trend. The glucosetrend can indicate a predicted change in the glucose level of thesubject. Additionally or alternatively, the system may estimate a secondglucose control parameter based on at least one of the an amount ofglucose control therapy received by the subject, a time of themedicament glucose control therapy received, an amount of insulin onboard, a glucose level signal, or another parameter. In someembodiments, the system can transmit to a remote electronic device(e.g., a graphical user interface, a mobile device, a remote computingenvironment) one or more of the therapy data or the glucose controlparameter. Additionally or alternatively, the system can receive atleast one of an amount of insulin on board or a value used in apharmacokinetic (PK) model of a control algorithm. In some embodiments,the method 5400 includes receiving from the first ambulatory medicamentpump, in response to determining that the at least one of a plurality ofdata retrieval conditions is satisfied at least one of the therapy dataor the glucose control parameter.

Medicament Pumps for Managing State Data

As noted above, glucose control therapy may require the coordination ofa plurality of elements within a system. Providing consistent glucosecontrol therapy from one medicament pump to another requires significantcoordination of the various devices as well as proper management of thestate data that is generated during a course of therapy provided to thesubject. Complicating matters further, a user may switch among a varietyof medicament pumps each with different operating parameters,encoding/decoding profiles, and/or other aspects. A medicament pump mayinclude any ambulatory medicament pump, such as a patch pump, but amedicament pump can include a medicament pen or a hospital infusionpump.

In order for data, such as state data, to be properly managed across thevariety of medicament pumps, the medicament pumps involved must be ableto properly communicate with one another. For example, each medicamentpump must be able to provide proper communication among the othermedicament pump(s) and/or with other devices to properly store andmanage the relevant data. This need to properly manage the relevantstate data, such as historical state data, often demands that the databe properly received, stored, and/or transmitted at appropriate timesand in an appropriate manner. Modern systems do not generally allow forproper data management that satisfy these needs. However, systems andmethods described herein help solve this deficiency in the art. As notedabove, although any medicament delivery system may be used in thesystems and methods described herein, for convenience reference will bemade to a medicament pump below.

Managing state data among a plurality of medicament devices can requireextensive care and coordination. One way to manage (e.g., store,transmit) the data among the variety of medicament pumps is to include aremovable data module. A removable data module can include one or moredifferent data storage devices, such as a data chip, a data card, amicrochip, a SIM card, a memory card or cartridge, or any otherremovable hardware memory. A first medicament pump can house orotherwise be operatively coupled to the removable data module. Theremovable data module can record and store state data obtained by thefirst medicament pump. At some point, the removable data module may beremoved from the first medicament pump to have the state data thereonread by another electronic device, such as a second medicament pump.

Another way to manage the state data is to transmit the data wirelesslyto the second medicament pump. This transmission may be directly (e.g.,via a short-range wireless connection) or indirectly through anintermediate electronic device (e.g., via a computing device connectedto a wide-area network connection).

The medicament pump be configured to execute one or more algorithms,such as the control algorithm described above. Using the one or morealgorithms, the medicament pump may be able to generate some or all ofthe state data described herein.

Another way to manage state data is by transferring data among aplurality of medicament pumps. FIG. 55A shows an example medicament pump5500 that is configured to store data on a removable data module 5508configured to be readable by a second ambulatory medicament pump. Themedicament pump 5500 includes a pump mechanism 5502, a pump controller5504, and may include additional elements. The data interface 5506 mayinclude one or more data interfaces, such as a wireless and/or wireddata interface.

The medicament pump 5500 may be any medicament pump described herein,such as the pump 100, the pump 212, and/or the medicament pump 5308. Thepump controller 5504 is configured to direct medicament from amedicament reservoir to the subject using the pump mechanism 5502.

The data interface 5506 may be in communication (e.g., wired, wireless)with one or more of a glucose sensor 5510 (e.g., via a glucose sensorconnection 5516), with a network 5512 (e.g., via a network connection5518), and/or with a user device 5514 (e.g., via a user deviceconnection 5522). Each of the connections 5516, 5518, 5522 may beone-way or two-way. The data interface 5506 may also be in communicationwith other elements of the medicament pump 5500, such as the pumpmechanism 5502 and/or the pump controller 5504. The communication amongone or more of the elements of the medicament pump 5500 may be via awired connection.

The network 5512 may include any network described above with respect tothe network 5312 in FIG. 53. Additionally or alternatively, the userdevice 5514 may include any user device described above with regard tothe user device 5316 in FIG. 53.

In some embodiments, the medicament pump 5500 includes a moduleinterface 5520 that is configured to receive the removable data module.The module interface 5520 can include a hardware receptacle. Thehardware receptacle can be shaped and/or otherwise adapted to fit theremovable data module therein. The module interface 5520 may beconfigured to allow access to the removable data module from an outsideof the medicament pump 5500. Additionally, or alternatively, the moduleinterface 5520 may be configured to house the removable data modulewithin the medicament pump 5500. For example, the removable data modulemay only be accessed by opening up the medicament pump 5500 in someembodiments. The module interface 5520 can retain the removable datamodule via an interference fit, a clamp or other retaining structure,and/or any other coupling means.

The medicament pump 5500 can include an electronic processor that isconfigured to execute instructions stored on a non-transitory memory toperform various functions, such as some of the ones described below. Themedicament pump 5500 can determine various state data, such as therapydata (e.g., glucose control therapy data), that is related to deliveryof glucose control therapy delivered to a subject. The therapy data caninclude one or more of an amount of insulin on board, a value used in apharmacokinetic (PK) model of a control algorithm, a time of a deliveryof medicament, an amount of delivery of medicament, and/or anotherparameter associated with therapy delivery. In some examples, thetherapy data includes version data. The version data can include atimestamp corresponding to a time associated with an update of thetherapy data. For example, the timestamp can indicate when the lastrecorded delivery of therapy occurred. Additionally, or alternatively,the version data may include an indicator of an ordering within asequence of delivery of the glucose control therapy. For example, theversion data may indicate where in the sequence a particular delivery oftherapy occurred. The version data may include a version code comprisingencoded time data associated with delivery of the glucose controltherapy. The version code may be encoded to identify a time of day ofdelivery of medicament, a time within a session of multiple deliveriesof medicament, an ordering within the session, or some other indicatorof when therapy was delivered.

As noted above, the medicament pump 5500 can generate one or more of aplurality of glucose control parameters. These parameters can include avariety of parameters, such as those described above, such as an insulindecay rate constant associated with a decay rate of insulin at asubcutaneous depot of the subject, a clearance time associated with anestimate of an amount of time for a bolus of insulin to be utilized bythe subject, an insulin rise rate constant associated with a rise rateof insulin in blood of the subject after a bolus of insulin, a half-lifevalue associated with when a concentration of insulin in blood plasma ofthe subject reaches half of a maximum concentration in the blood plasma,a weight of the subject, an age of the subject, a learned parameter,glucose level data of the subject, a model parameter associated with aPK model, a health state of the subject, a parameter associated with anactivity level of the subject, an aspect of a diet of the subject, abasal rate of insulin delivered to the subject, a correction factor, acarbohydrate ratio associated with the subject, a glucagon controlparameter, demographic information associated with the subject, asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament, or any other parameter that may beused in calculating a dose control signal, such as those describedherein.

The medicament pump 5500 can determine that the removable data module5508 has been removed from the module interface. The medicament pump5500 may determine this in a variety of ways. For example, themedicament pump 5500 may detect that the removable data module 5508 isno longer in electronic communication with the medicament pump 5500(e.g., the removable data module 5508 is not coupled to the moduleinterface). Additionally, or alternatively, the medicament pump 5500 mayreceive an indication from a user or from an electronic device that theremovable data module 5508 has been removed.

In response to determining that the removable data module 5508 has beenremoved, the medicament pump 5500 can transmit an indication that thedata module has been removed. For example, the medicament pump 5500 maytransmit an internal indication that the removable data module 5508 isno longer coupled to the medicament pump 5500. The indication mayautomatically trigger execution of a pump deactivation process that isconfigured to deactivate the first medicament pump. Deactivation caninclude shutting off (e.g., permanently, temporarily), conservingbattery, deleting stored data, transmitting an indication to a remoteelectronic device (e.g., the network 5512, the user device 5514),transmitting an indication to a graphical user interface, generating auser alert, and/or any other deactivation step. This may protect theprivacy of the data stored on the medicament pump 5500.

In some embodiments, the medicament pump 5500 can receive a glucoselevel signal from the glucose sensor 5510. The glucose level signal mayinclude encoded data, such as data corresponding to a glucose level ofthe subject and/or data corresponding to an indication of a glucosetrend in the subject. The glucose trend may indicate a predicted changein the glucose level of the subject. The medicament pump 5500 can decodethe encoded data obtain the glucose level of the subject and theindication of the glucose trend.

The medicament pump 5500 may be able to transmit to a user controlelement (e.g., a user device 5514) an indication that the removable datamodule is ready for removal. In response to transmitting the indication(or prior to transmitting), the medicament pump 5500 may be configuredto automatically or manually be deactivated.

In some embodiments, the medicament pump 5500 may be configured togenerate, a dose control signal configured to cause the pump controller5504 of the medicament pump 5500 to deliver medicament to the subject.This generation of the dose control signal can include calculatingregular correction boluses of glucose control agent. The medicament pump5500 may generate the dose control signal based on at least one or moreof the plurality of glucose control parameters and/or other state datastored thereon.

Additionally or alternatively, the medicament pump 5500 may beconfigured to wirelessly transmit the glucose control therapy data, oneor more of the plurality of glucose control parameters, and/or otherstate data to a remote electronic device (e.g., the network 5512, theuser device 5514). The medicament pump 5500 may receive and/or estimatean amount of insulin on board, a value used in a pharmacokinetic (PK)model of a control algorithm (see above), or other state data

In some embodiments, the medicament pump 5500 can transmit data to agraphical user interface. For example, the medicament pump 5500 maytransmit the state data that it has stored thereon. The medicament pump5500 may regularly and/or periodically store the determined/receivedstate data as needed. For example, data received from the glucose sensor5510 or other electronic device may be stored at or near the time thatthe data is received. Additionally or alternatively, data that iscalculated by the medicament pump 5500 may be stored at or near the timeof calculation. Over time, the medicament pump 5500 may catalogue thisdata on the local memory and/or on the removable data module 5508 foraccess later by the medicament pump 5500 and/or by a second (e.g.,replacement) medicament pump.

In some embodiments, the data may be stored in response to a triggeringcondition. The triggering condition can include one or more of a varietyof triggering conditions. These conditions may indicate or reflect achange that is occurring in the medicament pump 5500. For example, thetriggering condition may include a user request to store the data, auser indication of an intent to discard or otherwise dispose of themedicament pump 5500, and/or a user input initiating a replacementprocess for the medicament pump 5500. The triggering condition caninclude an alert indicating a malfunction associated with the medicamentpump 5500. The malfunction may include any problem with the medicamentpump 5500, such as a problem that may raise a potential concern ofability of the medicament pump 5500 to properly deliver medicament. Themalfunction can include any defect or malfunction described herein.

It may be advantageous to be able to wirelessly transmit data from afirst medicament pump to a second medicament pump. This may not only bemore convenient for a user but may better ensure that the data istransferred timely or at all. FIG. 55B shows another example medicamentpump 5500 that is configured to wirelessly transmit state data to asecond medicament pump. The medicament pump 5500 shown in FIG. 55B mayshare one or more features of the medicament pump 5500 shown in FIG.55A, and vice versa.

As noted above, the medicament pump 5500 may be configured to determinetherapy data (e.g., glucose control therapy data) that includes anamount of insulin on board, a time of a delivery of glucose controltherapy, and/or an amount of delivery of glucose control therapy.Additionally or alternatively, the medicament pump 5500 can generate oneor more glucose control parameters, such as those described herein.

The medicament pump 5500 may determine that the medicament pump 5500 isready to pair with a second medicament pump. This determination may beautomatic or manual and may be in response to the satisfaction of one ormore pairing conditions. The pairing conditions may include anoccurrence of a scheduled time, a transmission of a meal announcement(e.g., input by a user), a user request to pair the medicament pump to aremote electronic device, a user input initiating a replacement processfor the medicament pump, an indication that the second medicament pumpis ready to deliver medicament to the subject (e.g., is operativelyconnected to the subject), a sensory alarm configured to alert a userthat the historical pump data is ready for transmission, an alertindicating a malfunction associated with the medicament pump, adetermination that a level of medicament in a medicament reservoir ofthe first medicament pump is below a threshold level, a determinationthat an amount of available medicament of the medicament pump isinsufficient for a subject's medicament needs, a signal received from aremote electronic device requesting transmission of at least one of thetherapy data or the glucose control parameter, and/or any other pairingcondition.

In response to determining that at least one pairing condition issatisfied, the medicament pump 5500 can wirelessly transmit one or moreglucose control parameters and/or glucose control therapy data to asecond medicament pump (e.g., a replacement pump). In some embodiments,before transmitting the data, the medicament pump 5500 can firsttransmit a pairing request signal to the second medicament pump.Additionally or alternatively, the medicament pump 5500 may receive apairing confirmation signal from the second medicament pump. In someembodiments, the medicament pump 5500 transmits to a user controlelement (e.g., user device 5514) an indication that the second (e.g.,replacement) medicament pump is ready to be paired with the medicamentpump 5500.

The medicament pump 5500 may monitor the data transfer for errors. If anerror is detected, the medicament pump 5500 may automatically ormanually attempt to retransfer the data. If the number of failedattempts exceeds a threshold number, the state data may be reset to asafe state. In the safe state, the data may be restricted as describedabove.

The medicament pump 5500 may be able to transmit the data viashort-range and/or wide-area transmission technology. For example, itmay be advantageous for a user to quickly transmit the data to thereplacement medicament pump via short-range data transfer technology.Such transfer may be via radiative data transfer (e.g., via Bluetooh LowEnergy (BLE)) or inductive data transfer (e.g., near-field communication(NFC)). In some embodiments, power transfer may be possible from onemedicament pump to another. For example, the medicament pump 5500 or thereplacement medicament pump may not need to be powered for the datatransfer to take place. Thus, it may not always be necessary to receivea confirmation signal from one of the medicament pumps to initiate datatransfer. In some embodiments, the data may be transferred wirelesslyusing LTE. In some embodiments, the data may be transferred via a wiredconnection.

As noted above, in some embodiments the medicament pump 5500 canexecute, in response to transmitting data to the second ambulatorymedicament pump, a pump deactivation process configured to deactivatethe medicament pump 5500.

FIG. 56 shows a flow diagram illustrating an example method 5600 thatmay be used by a medicament pump (e.g., the medicament pump 5500, pump100, pump 212) to store data on a removable data module of a firstambulatory medicament pump configured to be readable by a secondambulatory medicament pump. At block 5602, the medicament pump candetermine glucose control therapy data comprising at least one of anamount of insulin on board, a time of a delivery of glucose controltherapy, or an amount of delivery of glucose control therapy. At block5604, the medicament pump generates one or more of a plurality ofglucose control parameters, such as those described above. At block5606, the medicament pump determines that the removable data module hasbeen removed from the module interface. At block 5608, the medicamentpump transmits an indication that the data module has been removed. Insome embodiments, the medicament may execute, in response totransmitting the indication that the data module has been removed, apump deactivation process configured to deactivate the medicament pump.Additionally or alternatively, the medicament pump may transmit one ormore of the received/generated data to a remote electronic device.

In some embodiments, the method 5600 incudes one or more additionalsteps. For example, the medicament pump may receive (e.g., from acontrol system, from a glucose sensor, from another medicament pump)and/or decode data corresponding to one or more of a glucose level ofthe subject or an indication of a glucose trend of the subject. Themedicament pump may generate (e.g., based on one or more glucose controlparameters) a dose control signal configured to cause the pumpcontroller of the medicament pump to deliver medicament to the subject.

FIG. 57 shows a flow diagram illustrating an example method 5700 thatmay be used by a medicament pump (e.g., the medicament pump 5500, pump100, pump 212) to wirelessly transmit from the medicament pump one ormore of a plurality of glucose control parameters and glucose controltherapy data to a second ambulatory medicament pump.

At block 5702, the medicament pump can determine glucose control therapydata comprising at least one of an amount of insulin on board, a time ofa delivery of glucose control therapy, or an amount of delivery ofglucose control therapy. At block 5704, the medicament pump generatesone or more of a plurality of glucose control parameters, such as thosedescribed above. At block 5706, the medicament pump determine that atleast one of a plurality of pairing conditions is satisfied to couplethe ambulatory medicament pump to the second ambulatory medicament pump.At block 5708, the medicament pump wirelessly transmit the one or moreglucose control parameters and the glucose control therapy data to thesecond ambulatory medicament pump, in response to determining that theat least one of the plurality of pairing conditions is satisfied.Additionally or alternatively, in response to determining that the atleast one of the plurality of pairing conditions is satisfied, themedicament pump may receive from a remote electronic device at least oneglucose control parameter.

In some embodiments, the medicament pump transmits a pairing requestsignal to the second ambulatory medicament pump and/or receives apairing confirmation signal from the second ambulatory medicament pump.In response to determining that at least one of the plurality of pairingconditions is satisfied, the medicament pump may transmit to the secondambulatory medicament pump at least one of an amount of insulin on boardor a value used in a pharmacokinetic (PK) model of a control algorithm.

Example Implementation of Glucose Level Control System

FIG. 58 illustrates a glucose level control system 5802 for regulatingthe blood glucose level of an animal subject (subject 5804), which maybe a human. The glucose level control system 5802 is an example of amedicament infusion system and may include any of the embodimentspreviously described above with respect to medicament infusion systems.

The subject 5804 may receive doses of insulin from one or more deliverydevice(s) 5806, for example infusion pump(s) coupled by catheter(s) to asubcutaneous space of the subject 5804. As described below, the deliverydevice(s) 5806 may also deliver a counter-regulatory agent orhyperglycemic agent, such as glucagon or dextrose, for control of theblood glucose level under certain circumstances. For the delivery ofboth insulin and a counter-regulatory agent (e.g., glucagon), thedelivery device(s) 5806 may be mechanically driven infusion mechanismshaving dual cartridges for insulin and the counter-regulatory agent,respectively. In the present description, reference is made to glucagonspecifically, but it is to be understood that this is for convenienceonly and that other counter-regulatory agents (e.g., dextrose) may beused. Similarly, the term “insulin” herein is to be understood asencompassing all forms of insulin-like substances including naturalhuman or animal insulin as well as synthetic insulin in any of a varietyof forms (commonly referred to as “insulin analogs”).

For online or autonomous operation, a glucose sensor 5808 is operativelycoupled to the subject 5804 to continually sample a glucose level of thesubject 5804. In some cases, the glucose sensor 5808 may be referred toas a continuous glucose monitoring (CGM) sensor, which may continuouslyor periodically measure or sense blood glucose levels of the subject5804 for at least a period of time. Sensing may be accomplished in avariety of ways, generally involving some form of physical coupling 5816between the subject 5804 and the glucose sensor 5808. A controller 5810may control operation of the delivery device(s) 5806 as a function of aglucose level signal 5812 from the glucose sensor 5808 and subject toprogrammed input parameters (PARAMS) 5814 which may be provided by auser such as the subject 5804, a parent or guardian of the subject 5804,or a healthcare provider (e.g., a clinician or doctor). One inputparameter for automatic operation may include the weight of the subject5804. In some cases, the glucose level control system 5802 can provideeffective automated control without receiving explicit informationregarding either meals that the subject 5804 has ingested or any other“feedforward” information, which is achieved in part by an adaptiveaspect to operation of the controller 5810. In other cases, the glucoselevel control system 5802 can use received information regarding eithermeals that the subject ingested, or plans to ingest, or other“feedforward” information to modify control of blood glucose and/ordelivery of insulin or counter-regulatory agent.

The controller 5810 is an electrical device with control circuitry thatprovides operating functionality as described herein. In one embodiment,the controller 5810 may be realized as a computerized device (e.g., ahardware processor) having computer instruction processing circuitrythat executes one or more computer programs each including respectivesets of computer instructions. In some cases, the processing circuitrywill generally include one or more separate processors 5820 along withmemory 5830 and input/output circuitry 5822 coupled to or incommunication with the separate processor 5820 (or separate processors5820), where the memory 5830 stores computer program instructions anddata, and the input/output circuitry 5822 can provide interface(s) toexternal devices such as the glucose sensor 5808 and delivery device(s)5806. In some cases, the input/output circuitry 5822 may provide a userinterface, or may operate with one or more processors (e.g., thecontroller 5810 or a separate processor 5820 included in the glucoselevel control system 5802 or in a separate computing system, such as asmartphone, a laptop computer, a desktop computer, a smartwatch, and thelike) to provide a user interface to a user (e.g., the subject 5804, aparent or guardian, or a clinician). In some cases, the input/outputcircuitry 5822 may include a touchscreen and/or a touchscreen controller5828 configured to control a touchscreen (not shown).

In some cases, the controller 5810 may perform all of the functionalityof the glucose level control system 5802. In such cases, the processor5820 may be optional or omitted. In other cases, the controller 5810 mayperform at least automated glucose control of the subject 5804, and oneor more separate processors 5820 may perform one or more additionaloperations of the glucose level control system 5802 (or medicamentpump), such as tracking occurrences of hyperglycemic or hypoglycemicevents or risk events, outputting data to a user, controlling orinitiating communication with another computing system, regulatingaccess to the glucose level control system 5802, or other operationsunrelated to operation of a medicament pump or the delivery device(s)5806.

The input/output circuitry 5822 may control communication with one ormore other computing systems and/or with a user. In some cases, theinput/output circuitry 5822 may include one or more separate interfacecircuits or controllers to facilitate user interaction and/orcommunication. For example, the input/output circuitry 5822 may includeuser interface 5824, network interface 5826, and/or a touchscreencontroller 5828.

The user interface 5824 may include any circuitry or processors that mayoutput a user interface to a user and/or receive user input from theuser via the user interface. The user interface 5824 may receive one ormore signals from a separate processor 5820 corresponding to a userinterface. The user interface 5824 may control a display to present theuser interface to a user based on the one or more signals received fromthe separate processor 5820. Further, the user interface 5824 mayinclude any circuitry that can receive a signal corresponding to aninteraction by a user with a user interface and can provide the signalto the separate processor 5820 and/or controller 5810 for furtherprocessing. In some cases, the user interface circuitry may be replacedby a touchscreen controller 5828 that can control a touchscreeninterface. In other cases, the touchscreen controller 5828 may be inaddition to the user interface 5824.

The network interface 5826 may include any circuitry that enablescommunication with a wired or wireless network. The network interface5826 may include one or more network interface cards and/or wirelessradios (e.g., a Bluetooth radio, a Bluetooth Low Energy (BLE) radio, a4g LTE radio, a 5G radio, a ND-LTE radio, and the like).

The memory 5830 can include non-volatile memory and/or volatile memory.The non-volatile memory may include flash memory or solid-state memory.

The glucose level control system 5802 is also able to operate in anoffline manner in which it is used to provide delivery of insulin (andpotentially glucagon as well), independent of or without receipt ofglucose levels reported by the glucose sensor 5808. For example, incases where the glucose sensor 5808 needs replacing, is not properlyconnected to the subject 5804, or is defective, the glucose levelcontrol system 5802 may operate in an offline manner without input fromthe glucose sensor 5808. Thus, overall operation may be divided betweenonline periods each including a succession of sampling intervals when aglucose level signal 5812 is available, and offline periods eachincluding a succession of sampling intervals when the glucose levelsignal 5812 is either completely or intermittently unavailable. Thedescription below uses the terms “online” and “offline” for theseperiods. Also, offline operation may be user-selected for some reasoneven when a glucose level signal 5812 is available for use.

User control inputs (user control inputs 5818 or USER CNTLs) may beprovided via a local or remote user interface of some type. In someembodiments, the user interface may resemble that of conventionalinsulin pumps or similar devices, e.g., by including control buttons forcommanding the delivery of a bolus and perhaps a small display. In otherembodiments, the system may have a wired or wireless interface to aremote device that may incorporate a fuller-function user interface,such as a smartphone, smartwatch, laptop computer, desktop computer,cloud computing service, or other wearable device or computing device.In some cases, the wireless interface may provide access to a local areanetwork, such as a personal home network, a company network, orotherwise. Alternatively, or in addition, the wireless interface mayprovide a direct connection between local devices available to a user(e.g., via Bluetooth or other near field communication technologies). Insome cases, the wireless interface may provide access to a wide areanetwork, such as, but not limited to, the Internet. For example, thewireless interface may include a cellular interface that permits accessto a network via a 4G or 5G cellular connection. In some cases, thecellular interface may be a low power interface, such as narrowband LTEor other Internet of Things (IoT) interfaces.

In offline mode, the glucose sensor 5808 may be absent, non-functioning,or not coupled to the subject 5804. As such, in offline mode, the bloodglucose level signal 5812 may not be available to control automaticoperation. In some cases, a user may provide one or more blood glucosemeasurements to the glucose level control system 5802 to facilitateautomatic operation of the control system 5802. These measurements maybe provided over a particular time period. Alternatively, or inaddition, the glucose level control system 5802 may use a therapyhistory and/or a history of prior glucose control measurements tofacilitate automatic operation of the glucose level control system 5802for at least a particular time period.

The description herein refers to a “user” as the source of the usercontrol inputs 5818. The “user” as used herein may be the subject 5804,a parent or guardian of the subject 5804, a healthcare provider (e.g., aclinician, doctor, or other person who may provide medical care to thesubject), or any other user who may be authorized to help manage therapyof the subject 5804. In certain implementations, the glucose levelcontrol system 5802 is a personal device worn by a subject 5804 forcontinual glucose control. In some such implementations, the user andsubject 5804 may be the same person. In other implementations, there maybe another person involved in the care of the subject 5804 and providingcontrol input, and in such implementations, that other person has therole of user.

Example Controllers for a Glucose Level Control System

FIG. 59 shows an example structure of the controller 5810 in accordancewith certain embodiments. The controller 5810 illustrated in FIG. 59 mayrepresent a physical structure with different controllers or processors,or a logical structure that is implemented by one or more physicalprocessors. In other words, a single processor may be used to implementeach of the controllers illustrated in FIG. 59, each controller may beimplemented by its own processor, or certain processors may implementmultiple, but not necessarily all, of the controllers illustrated inFIG. 59 as part of the controller 5810. Moreover, although thecontrollers of FIG. 59 are illustrated as part of the controller 5810,in some implementations, one or more of the controllers may be separatefrom the controller 5810.

The controller 5810 may include four separate controllers, namely aglucagon (or counter-regulatory agent) glucagon controller 5902, a basalinsulin controller 5904, a corrective insulin controller 5906 (or modelpredictive controller), and a priming insulin controller 5908 (or mealcontroller). The basal insulin controller 5904 includes a nominal ratecontroller 5910 and a modulating controller 5912. As shown, the glucagoncontroller 5902 generates a glucagon dose control signal 5914 providedto a glucagon delivery device 5806-1. Respective outputs 5916, 5918, and5920 from the controllers 5904, 5906, and 5908 may be combined to forman overall insulin dose control signal 5922 provided to insulin deliverydevice(s) 5806-2. As shown, the output signal 5916 from the basalinsulin controller 5904 may be formed by a combination of respectiveoutputs of the nominal rate controller 5910 and a modulating controller5912. The insulin delivery device(s) 5806-2 may include devices tailoredto deliver different types and/or quantities of insulin, and the exactconfiguration may be known to and/or under the control of thecontrollers 5904-5908. For ease of description, the collection of one ormore insulin delivery device(s) 5806-2 is referred below to in thesingular as an insulin delivery device 5806-2.

Also shown in FIG. 59 are input/output signals of the variouscontrollers, including the glucose level signal 5812, programmed inputparameters (PARAMS)s 5814 and user control inputs 5818 as well as a setof inter-controller signals 5924. The inter-controller signals 5924enable communication of information from one controller, where theinformation is developed or generated, to another controller where theinformation may be used for that controller's control function.

The controllers 5902-5908 may be operated in either the online/automaticmode or in the offline mode. In the automated mode, the correctiveinsulin controller 5906 regulates glucose level using a control schemesuch as described in U.S. Pat. No. 7,806,854, the contents of which arehereby incorporated by reference in its entirety herein. The basalinsulin controller 5904 and priming insulin controller 5908 may performadaptive automated control as described in International PatentApplication Publication WO 2012/058694 A2, the contents of which arehereby incorporated by reference in its entirety herein. The controllers5902-5908 generally employ control methods or algorithms that includecontrol parameters that are mathematically combined with reportedglucose values to generate an output value that is converted (eitherdirectly or via additional conditioning) into the dose control signals5914, 5922. For example, the control scheme described in U.S. Pat. No.7,806,854 includes a generalized predictive control (GPC) method thatincorporates a variety of control parameters. The control algorithms aregenerally adaptive, meaning that control parameters are dynamicallyadjusted during operation to reflect changing operating circumstancesand a “learning” aspect—by monitoring its own operation, the algorithmadjusts its operation to be more specifically tailored to the individualuser, enhancing the algorithm's effectiveness and reducing or avoiding aneed for additional explicit input information about the user. It shouldbe noted that the programmed input parameters (PARAMS)s 5814 may formpart of the control parameters used by the control algorithm. Othercontrol parameters are internal parameters according to the specifics ofthe algorithm, and selected ones of those internal control parametersare dynamically adjusted to realize the adaptation of the controlalgorithm.

One feature of operation is the ability of the controllers to learn fromrecent past periods of online operation and to use that learning duringoffline operation. U.S. Pat. No. 10,543,313, the contents of which arehereby incorporated by reference in its entirety herein, describes twomethods that are usable independently or together in offline operation.A first method automatically calculates the correct size of a correctionbolus of insulin at a time of receiving an isolated glucose measurement,the correction bolus then being administered by the system in responseto a user control input. A second method automatically calculates thecorrect size of a meal bolus of insulin and administers it in responseto a user control input. Both methods utilize information obtainedduring past periods of online operation to automatically calculatecorrect values, freeing the user of a need to make the calculation orprovide a correction factor.

Carbohydrate Therapy Equivalence Tracking

Hyperglycemia is a condition that occurs when the levels of sugar orglucose in the blood exceeds a particular level (e.g., 180 mg/dL). Thiscondition may occur in diabetics. To help reduce the occurrence ofhyperglycemia, a subject may use an automated glucose level controlsystem, which may automatically provide insulin to a subject using amedicament pump. The administered insulin may help control the bloodglucose level of the subject by consuming glucose in the subject.

Hypoglycemia is a condition that occurs when the levels of sugar orglucose in the blood are below a particular level (e.g., 70 mg/dL). Thiscondition may have adverse consequences including loss of consciousness,seizures, and death. The levels of blood sugar that lead tohyperglycemia and hypoglycemia may vary from patient to patient. Toreduce the risk of hypoglycemia, a subject may consume carbohydrates toincrease blood sugar. Because of the severe consequences associated witha hypoglycemic event, subjects usually consume carbohydrates thatmetabolize quickly. These carbohydrates are often unhealthy but arepreferable to the occurrence of a hypoglycemic event. For example, thecarbohydrates may include candy bars with a lot of refined sugar.

A bihormonal glucose-control system may reduce the risk of occurrence ofhypoglycemia by including, in addition to insulin, a counter-regulatoryagent (e.g., Glucagon) that can be administered to a subject when theblood glucose level drops too low (e.g., below 50 mg/dL). For subjectswho do not have a bihormonal glucose-control system, it may be useful tounderstand the reduction in carbohydrate therapy, or the consumption ofcarbohydrates to address hypoglycemic events or potential hypoglycemicevents, that can be achieved by switching to a bihormonalglucose-control system. Further, it may be useful for subjects who dohave a bihormonal glucose-control system to understand the reduction incarbohydrate therapy obtained by having the bihormonal glucose-controlsystem. For example, understanding the amount of carbohydrate therapyconsumed or avoided can be important in monitoring the subject'snutrition intake. While monitoring nutrition in take is important forall people, it is particularly important for diabetics because diabeticsmust balance eating healthy with ensuring that their blood sugar ismaintained in a particular range to avoid both hyperglycemia andhypoglycemia.

The present disclosure relates to a system that can perform acomputer-implemented method of generating an indication of totalcarbohydrate therapy over a time period in a subject using a medicamentpump configured to deliver at least insulin therapy to the subject. Thesystem may be an automated glucose level control system (e.g., theglucose level control system 5802) that includes a hardware processor(e.g., controller 5810) for determining dose control signals to providethe medicament pump (e.g., delivery device(s) 5806). In some cases, themedicament pump may be configured to deliver both insulin therapy andcounter-regulatory agent (e.g., Glucagon) therapy. Alternatively, thesystem may be separate from the glucose level control system but mayreceive blood glucose information from the glucose level control system.For example, the system may be personal computing system or a cloudcomputing system that can received blood glucose information from theglucose level control system.

The system may receive or determine a glucose level of a subject (e.g.,subject 5804). The glucose level of the subject may be determined basedon a signal (e.g., a glucose level signal) received from a continuousglucose monitoring (CGM) sensor (e.g., glucose sensor 5808) thatcorresponds to the glucose level of the subject. In some cases, theglucose level may be determined from an isolated glucose measurement,such as may be obtained using a glucose measurement kit and/or glucosepaper.

Using at least the glucose level of the subject, the system candetermine whether a triggering event for raising the subject's bloodglucose level has occurred. The triggering event may include a bloodglucose level that indicates an occurrence of a hypoglycemic event or arisk of the occurrence of a hypoglycemic event exceeding a riskthreshold within a particular period of time. A risk of a hypoglycemicevent may be determined when a glucose level of the subject falls belowa glucose threshold. This glucose threshold may vary for differentsubjects and may, in some cases, be specified by the subject or acaregiver (e.g., healthcare provider, parent, or guardian). Thus, insome cases, different triggering events may be defined based on a risktolerance of a subject to an occurrence of hypoglycemia or to possibledifferent preferences for an amount of blood glucose to be present inthe subject. Different subjects may prefer that blood glucose bemaintained, or attempt to be maintained, at different levels due, forexample, to differences in activity levels or metabolism by differentsubjects. Determining the risk of the occurrence of a hypoglycemic eventmay include receiving an indication of a risk of hypoglycemia from aglucose sensor or a prediction of a glucose level at a future time. Forexample, a determination of an imminent risk of hypoglycemia maycomprise a determination that the subject's blood glucose level isexpected to be below 60 mg/dl within the next 5-15 minutes.

Responsive to the triggering event, the system may determine an amountof counter-regulatory agent to administer, or an amount ofcounter-regulatory agent that would be administered if the glucose levelcontrol system included the capability of administering acounter-regulatory agent. In some cases, the counter-regulatory agent isadministered by, for example, the automated glucose level controlsystem. In other cases, the counter-regulatory agent is notadministered. For example, the automated glucose level control systemmay not be capable of delivering the counter-regulatory agent. Asanother example, the automated glucose level control system may becapable of delivering the counter-regulatory agent but may not have adose of the counter-regulatory agent available.

The system can use the indication of the counter-regulatory agent thatis administered or that would be administered to determine acorresponding amount of carbohydrates. The corresponding amount ofcarbohydrates may be indicative of the amount of carbohydrates that wereconsumed to prevent the hypoglycemic event, to reduce the risk of thehypoglycemic event, or in response to an occurrence of a hypoglycemicevent. Alternatively, or in addition, the corresponding amount ofcarbohydrates may be indicative of the amount of carbohydrates thatwould have been consumed if the counter-regulatory agent were notavailable.

The corresponding amount of carbohydrates may be obtained from a mappingbetween amounts of a counter-regulatory agent and amounts ofcarbohydrates. In some cases, the mapping may be based on a measuredequivalency between carbohydrates and a counter-regulatory agent.Alternatively, or in addition, the mapping may be between a determinedamount of counter-regulatory agent and an amount of carbohydrate asubject indicates he or she normally consumes when determining that ahypoglycemic event may occur.

The mapping may be implemented by a lookup table that maps differentamounts of counter-regulatory agent to different corresponding amountsof carbohydrates. In some cases, a single quantity of counter-regulatoryagent may map to different amounts of carbohydrates depending on thetype of carbohydrate consumed (e.g., simple vs complex carbohydrates, orthe type of candy bar consumed, etc.). Alternatively, the mapping may bebased on a formula that converts an amount of counter-regulatory agentto an amount of carbohydrates based on a correspondence between theamount of counter-regulatory agent and the amount of carbohydrates. Thedetermination of a relationship between the counter-regulatory agent andcarbohydrates may be based on clinical tests comparing carbohydrates tothe counter-regulatory agent (e.g., Glucagon, dextrose, etc.). Further,the mapping may be based at least in part on a subject's preferredcarbohydrate source and/or characteristics of the subject (e.g.,weight).

In some cases, the system can track a number of hypoglycemic events or anumber of occurrences of a trigger indicating an impending risk of ahypoglycemic event within a particular time period. The time period maybe days, weeks, months, years, or any other period of time over which itis desirable to determine a relationship between carbohydrates consumedor avoided based on the lack of availability or availability of acounter-regulatory agent. In some cases, the tracking of carbohydratetherapy may be based on a number of hypoglycemia events or hypoglycemiarisk events instead of or in addition to a time period.

For each occurrence of a hypoglycemic event or occurrence of a triggerindicating an impending risk of a hypoglycemic event, the system candetermine an estimate of the carbohydrate therapy saved or that wouldhave been saved by having access to the counter-therapy agent. Thesystem can generate a report for the time period that indicates thetotal carbohydrate saved or that would have been saved with access tocounter-regulatory agent. The report may include an aggregate or sum ofthe carbohydrate therapy required or saved during the time period. Thistime period may be days, weeks, months, years, or since a particulartime (e.g., since the subject starting using the system). Further, thereport may indicate the type of carbohydrates typically consumed by thesubject when responding to a hypoglycemic event or a risk of animpending hypoglycemic event. This report can be presented to thesubject, a healthcare provider, and/or a parent or guardian of thesubject. The healthcare provider can use this report to help care forthe subject. For example, the healthcare provider can use the report togenerate a nutrition plan for the subject that accounts for thecarbohydrates consumed to maintain the blood glucose level within adesired or setpoint range.

The report may include a range of carbohydrate therapy avoided or likelyconsumed to address the risk of hypoglycemia events. Further, the reportmay include an amount of calories saved or not consumed, an amount ofsugar avoided, an amount of food not consumed, a likely weight gainavoided, etc. based on the use of a counter-regulatory agent in place ofcarbohydrate therapy.

Carbohydrate Therapy Equivalence Tracking Process

FIG. 60 presents a flowchart of a carbohydrate therapy equivalencetracking process 6000 in accordance with certain embodiments. Theprocess 6000 may be performed by any system that can track the glucoselevel of a subject over time and identify hypoglycemic events, oroccurrences when a risk of a hypoglycemic event satisfies a threshold(e.g., when the risk of the hypoglycemic event matches or is above aparticular probability). For example, the process 6000 may be performedby one or more elements of the glucose level control system 5802. Insome cases, at least certain operations of the process 6000 may beperformed by a separate computing system that receives indications ofblood glucose levels of the subject 5804 from the glucose level controlsystem 5802 and/or indications of hypoglycemic events (or identifiedabove threshold hypoglycemic risk events). Although one or moredifferent systems may perform one or more operations of the process6000, to simplify discussions and not to limit the present disclosure,the process 6000 is described with respect to particular systems.

The process 6000 begins at block 6002 where the glucose level controlsystem 5802 receives a glucose level of a subject 5804. Receiving theglucose level may include receiving a glucose level signal correspondingto a glucose level of the subject. The glucose level signal may bereceived from the glucose sensor 5808 (e.g., a CGM sensor).Alternatively, or in addition, the glucose level may be received from auser that provides the glucose level to the glucose level control system5802 via a user interface, such as a user interface generated by theseparate processor 5820 that may be output on a touchscreen by thetouchscreen controller 5828. The glucose level received from the usermay be a glucose level measured using an alternative sensor ormeasurement mechanism (e.g., diabetes measurement strips) that may beused in place of the glucose sensor 5808.

At bock 6004, the glucose level control system 5802 determines based atleast in part on the glucose level that a triggering event for raisingthe blood glucose level of the subject 5804 has occurred. The triggeringevent may include a determination that a hypoglycemic event or anepisode of hypoglycemia is present or is occurring in the subject 5804.Alternatively, or in addition, the triggering event may include adetermination that there is an impending risk of hypoglycemia in thesubject 5804, or an impending risk that a hypoglycemic event will occurwithin a particular amount of time in the subject 5804. Thedetermination of the hypoglycemic event or the risk of a hypoglycemicevent occurring may be determined by comparing the glucose level of thesubject to a glucose threshold. Alternatively, or in addition, thedetermination of the hypoglycemic event or the risk of a hypoglycemicevent occurring may be determined by comparing a trend and/or rate ofchange (e.g., rate of decrease) in the glucose level to a threshold. Insome cases, the particular blood glucose level and the trend in theblood glucose level may be combined to determine a risk of hypoglycemia.For example, if the glucose level is low (e.g., below a particularthreshold, such as 60 mg/dL), but a determined trend in the glucoselevel is upwards, then a risk of hypoglycemia may be lower than if theglucose level is above the threshold, but the determined trend in theglucose level is downwards towards a threshold. In some cases, thethreshold(s) used to determine whether a hypoglycemic event is occurringor to determine that there is an above threshold risk of hypoglycemiaoccurring may vary based on physiological characteristics of the subject5804. The physiological characteristics may be based on physiologicalcharacteristics associated or shared among groups of patients (e.g.,gender, age, weight) or may be specific to the particular subject 5804.For example, thresholds associated with a risk of hypoglycemia may bedetermined based on determined glucose levels of the subject 5804 duringprior occurrences of hypoglycemia as determined by the glucose levelcontrol system 5802 or based on clinical data specific to the subject5804.

In response to the triggering event at the block 6004, the glucose levelcontrol system 5802 determines an amount of counter-regulatory agent atblock 6006. The glucose level control system 5802 may determine theamount of counter-regulatory agent based at least in part on the bloodglucose level of the subject 5804, the amount or percentage of risk ofhypoglycemia occurring (e.g., a 99% risk or probability of hypoglycemiamay trigger a larger counter-regulatory agent dose than a 75% risk orprobability of hypoglycemia), physiological characteristics of thesubject 5804, a trend in the blood glucose level of the subject 5804, ora type of counter-regulatory agent.

In some cases, the glucose level control system 5802 may use a deliverydevice 5806-1 to deliver the determined amount of counter-regulatoryagent to the subject 5804. The counter-regulatory agent may be deliveredto the subject 5804 in response to the impending risk of hypoglycemia orthe episode of hypoglycemia, and/or in response to the glucose levelsatisfying or falling below a threshold glucose level. The thresholdglucose level or the determination of whether to deliver thecounter-regulatory agent may be based on physiological characteristicsof the subject 5804 and/or the risk tolerance of the subject 5804 to ahypoglycemic event. It should be understood that, in the presentcontext, risk tolerance generally does not refer to a user's subjectivepropensity for risk. Instead, the risk tolerance is typically anobjective determination of how likely the subject 5804 is to have ahypoglycemic event, or for symptoms of hypoglycemia to occur, when theblood glucose level of the subject 5804 is at a particular level. Thisrisk tolerance may be determined based on a history of hypoglycemia, orlack thereof, in the subject 5804 at particular blood glucose levelsand/or based on clinical data obtained for the subject 5804.

In other cases, the glucose level control system 5802 may not delivercounter-regulatory agent to the subject 5804 because, for example, theglucose level control system 5802 may not be capable of deliveringcounter-regulatory agent or because the cartridge holding thecounter-regulatory agent may be empty or have less than a thresholdamount of counter-regulatory agent remaining.

At block 6008, the glucose level control system 5802 determines a doseof carbohydrate therapy based at least in part on the counter-regulatoryagent. The carbohydrate therapy may refer to carbohydrates consumed toprevent or respond to an occurrence of hypoglycemia. The carbohydratesmay include any type of carbohydrate that the subject 5804 may consumeto prevent or respond to an occurrence of hypoglycemia, and typicallyincludes fast-acting carbohydrates, which may include sugary foods thatare easily converted into sugars in the human body. For example, thecarbohydrate may be a candy bar, soda, fruit juice, or other foods thatmay have a lot of sugar or refined sugars.

Determining the dose of carbohydrate therapy may include accessing amapping between the counter-regulatory agent and carbohydrates. Thismapping may be stored in, and accessed from, the memory 5830 and/or maybe accessed from another computing device. The glucose level controlsystem 5802 may determine the dose of carbohydrate therapy based atleast in part on the mapping and the amount of the counter-regulatoryagent. In some cases, the mapping may vary based on the type ofcounter-regulatory agent and/or the type of carbohydrates. The type ofcounter-regulatory agent may be identified by a user or mayautomatically be determined based on a medicament cartridge installed orinserted into the glucose level control system 5802. Further, the typeof carbohydrates may be specified by a user and may include an identityof the type of carbohydrates usually consumed by the subject 5804 whenresponding to an occurrence or a risk of an occurrence of hypoglycemia.For example, the user may specify, via a user interface, whether thesubject usually consumes a candy bar or fruit juice, or the size of thecarbohydrate usually consumed when responding to an occurrence or a riskof an occurrence of hypoglycemia.

In some cases, the mapping between the counter-regulatory agent andcarbohydrates may be generated based on a clinical comparison of thecounter-regulatory agent to the carbohydrates. Alternatively, or inaddition, the mapping may be based at least in part on a physiologicalcharacteristic of the subject 5804.

The mapping may be stored in a lookup table or other data structure thatcan store relationships between different carbohydrates andcounter-regulatory agents. The mapping may be between differentquantities and/or types of carbohydrates and different quantities and/ortypes of counter-regulatory agent. Alternatively, or in addition, themapping may be a formula that relates the carbohydrates to thecounter-regulatory agent or vice versa. For example, the glucose levelcontrol system 5802 may use the determined amount of counter-regulatoryagent as an index to a lookup table to determine a correspondingquantity of carbohydrates. Alternatively, the glucose level controlsystem 5802 may apply the determined amount of counter-regulatory agentto a formula to calculate a corresponding quantity of carbohydrates.This formula may be generated based on the type of counter-regulatoryagent and/or carbohydrates, physiological characteristics of the user,and/or clinical data.

In some cases, the mapping may vary based on the glucose level controlsystem 5802. For example, the glucose level control system 5802 mayinclude a first mapping when the glucose level control system 5802 (ormedicament pump thereof) is a bi-hormonal pump configured to deliverinsulin and counter-regulatory agent therapy to the subject, and mayinclude a second mapping when the glucose level control system 5802 isnot configured to deliver the counter-regulatory agent therapy to thesubject 5804. In some cases, the glucose level control system 5802 maystore both mappings in the memory 5830. For example, the glucose levelcontrol system 5802 may use the first mapping when counter-regulatoryagent is available and may use the second mapping whencounter-regulatory agent is not available. The mappings may vary for anumber of reasons including because a bi-hormonal glucose level controlsystem 5802 may more precisely control the occurrence of hypoglycemicevents due to the availability of counter-regulatory agent, which maytherefore alter the frequency and type of carbohydrates that a subjectmay consume.

At block 6010, the glucose level control system 5802 outputs anindication of the dose of carbohydrate therapy. Outputting theindication of the dose of carbohydrate therapy may include outputting anindication of the dose of carbohydrate therapy on a display forpresentation to a user. Further, the indication of the dose ofcarbohydrate therapy may be transmitted to another computing system fordisplay or aggregation with other therapy data associated with thesubject 5804, such as therapy data used by a clinician to help managerthe subject's 5804 care. In some cases, the indication of the dose ofcarbohydrate therapy may be included in a report corresponding to careof the subject 5804.

In certain embodiments, the operations of the process 6000 are performedor repeated over a period of time. For example, the operationsassociated with the block 6002-6008 may be repeated one or more timesover the period of time. In such cases, the determined doses ofcarbohydrate therapy may be aggregated for the period of time todetermine a total carbohydrate therapy for the period of time. Further,the block 6010 may include outputting an indication of the dose ofcarbohydrate therapy for each individual time that a dose ofcarbohydrate therapy is determined and/or the aggregated determineddoses of carbohydrate therapy for the period of time. The period of timemay be any time period. For example, the period of time may be a day,week, month, year, since the subject 5804 began using the glucose levelcontrol system 5802, since a user obtained or ceased obtaining access toa counter-regulatory agent, or any other period of time. In some cases,the period of time is defined by the occurrences of hypoglycemic eventsor occurrences of the risk of hypoglycemia satisfying a threshold. Forexample, the period of time may be the time associated with 5, 10, 15,100, or any other number of hypoglycemic events or occurrences of therisk of hypoglycemia satisfying a threshold.

The indication of total carbohydrate therapy may correspond to areduction in carbohydrates consumed by the subject 5804 because, forexample, of the availability of counter-regulatory agent to the glucoselevel control system 5802, and consequently, the subject 5804. Thus, theindication of total carbohydrate therapy may correspond to a reductionin carbohydrates achievable by an availability to the subject 5804 ofthe counter-regulatory agent. Further, the indication of totalcarbohydrate therapy may correspond to an amount of counter-regulatoryagent provided or that can be provided to the subject as a substitutefor carbohydrates.

The particular carbohydrates consumed, or the amount of carbohydratesconsumed by each subject or during each hypoglycemic event, may vary.For example, a subject 5804 may consume a particular candy bar when thesubject's 5804 measured blood sugar level is too low or when the subjectfeels that the blood sugar level is likely low (e.g., begins to feelsome hypoglycemic effects). The subject may consume the whole candy baror may consume a portion. Some of the candy bar may be lost to thesubject (e.g., fall on the ground). In other cases, the subject may havedifferent candy bars available, or other refined sugar sources, duringdifferent hypoglycemic events. Thus, even though there may be anobjective mapping between carbohydrates and counter-regulatory agent,the amount of carbohydrates consumed or avoided due to the availabilityof counter-regulatory agent may vary for each hypoglycemic event.Accordingly, the indication of total carbohydrate therapy avoided, orthat could be avoided if counter-regulatory agent were available, mayindicate a range of carbohydrates that may potentially be replaced bythe availability of counter-regulatory agent.

In some cases, the indication of carbohydrate therapy or totalcarbohydrate therapy may include one or more of an indication ofcalories, an indication of carbohydrates, an indication of a measure ofsugar, an indication of a quantity of food, or an indication of weightof the subject attributable to the carbohydrate therapy. The indicationsmay be associated with what is consumed due to a lack ofcounter-regulatory agent, or what is avoided based on the availabilityof counter-regulatory agent. For example, the indication of calories maybe the number of calories not consumed because of the presence of thecounter-regulatory agent. Advantageously, the availability of therapyinformation relating to the carbohydrate therapy or avoided carbohydratetherapy can assist in patient care. For example, a subject can reducerefined sugar consumption that can have a number of health consequences.Further, a healthcare provider can better help a subject control his orher weight based on the carbohydrate information.

The indication of carbohydrate therapy may be presented to a user in anypresentable form. For example, the indication of carbohydrate therapymay be presented as a table, a chart, a graph, a histogram, or otherdata presentation tool for indicating the reduction in carbohydratesover time that is achieved by the presence of counter-regulatory agentor that could be achieved by the use of counter-regulatory agent for theparticular subject 5804. It should be understood that the indication ofcarbohydrate therapy data may vary for different users due todifferences in physiological characteristics of the users, differencesin the diabetes of each user, differences in lifestyle of each user,among other factors. Advantageously, by using the glucose level controlsystem 5802 to track the carbohydrate therapy of the subject 5804 or todetermine the carbohydrate therapy avoided or avoidable associated withcounter-regulatory agent, management of the subject's 5804 blood glucoselevel can be personalized.

Additional Carbohydrate Therapy Equivalence Tracking Embodiments

People with diabetes often consume oral carbohydrates for the purpose oftreating or preventing hypoglycemia. Such extra carbohydrates can haveunhealthy consequences, contributing to weight gain being one of them.Having a bihormonal glucose-control system that infuses acounter-regulatory agent (e.g., Glucagon) to reduce the frequency,extent, and duration of hypoglycemia can significantly reduce the amountof oral carbohydrates that are needed “medicinally” to treat or preventhypoglycemia.

Certain embodiments of the present disclosure relate to a method fortranslating an amount of online counter-regulatory dosing (e.g.glucagon) computed by an autonomous glucose-control system to an amountof carbohydrates that the user is estimated to have been spared fromneeding by virtue of the counter-regulatory dosing, or that the userwould be spaced from needing if the user had access to thecounter-regulatory agent. In a bihormonal autonomous glucose-controlsystem that infuses both insulin and a counter-regulatory agent/hormone,the method may include a mapping between the online counter-regulatorydosing, which was delivered to treat or prevent low glucose levels, andoral carbohydrates that are estimated to have otherwise been required toachieve a comparable safe control situation (had the counter-regulatorydosing not been delivered). In an insulin-only autonomousglucose-control system, where doses of a counter-regulatoryagent/hormone are not delivered, but are still computed online, themethod may include a mapping between the computed onlinecounter-regulatory dosing and an estimated amount of oral carbohydratesthat the subject will likely have been spared from needing to consume totreat or prevent low glucose levels had the counter-regulatory agentbeen available and its doses actually delivered.

Without loss of generality, embodiments disclosed herein include anautonomous glucose-control system where the counter-regulatory agent isglucagon. However, other medicaments and/or counter-regulatory agentsmay be utilized. The method may include relating computed onlineglucagon dosing with consumed oral carbohydrates for the treatment orprevention of low glucose levels (“treatment carbs”) as observed in realuse (e.g., during clinical studies) in the insulin-only configuration,and relating the relationship between the counter-regulatory agent andcarbohydrates to a similar relationship between delivered onlineglucagon doses (or other counter-regulatory agent) and similarlyconsumed oral carbohydrates in the bihormonal (insulin-glucagon)configuration.

Using data gathered from real use (e.g., clinical studies), arelationship between the consumed treatment carbs in an insulin-onlyconfiguration, C_(io), and the online computed (but not delivered)glucagon dosing, Gc, can be described by the relationshipC_(io)=R_(io)(x)*Gc, where R_(io)(x) may be a relating factor that canbe a function of several dependencies that are included in vector x.Such dependencies can include the specific insulin and/or glucagon beingused (e.g., their clinical properties), and/or the pharmacokineticsettings assumed by the control system in relation to insulin and/orglucagon. The dependencies can also include the user's body mass and theglucose target used by the glucose-control system. In some embodiments,R_(io)(x) may be a constant, or R_(io)(x)=R_(io), for a systemexhibiting limited variation in the relationship between C_(io) andG_(c) (e.g., due to limited effect, or limited or no variation in theassociated dependencies).

Similar to the insulin-only configuration, from real-use data, arelationship between the consumed treatment carbs in a bihormonal(insulin-glucagon) configuration, C_(bh), and the online deliveredglucagon dosing, G_(d), can be described by the relationshipC_(bh)=R_(bh)(x)*G_(d), where R_(bh)(x) may be described in a similarfashion to R_(io)(x) above. In some cases, the quantities C_(io), G_(c),C_(bh), and G_(d) can refer to daily amounts, as averaged over someperiod of use (e.g., a week). In some cases, the quantities C_(io),G_(c), C_(bh), and G_(d) can refer to average daily amounts per bodymass of the user, in which case dependency on body mass can beeliminated from x.

In cases where G_(c) is computed, but no glucagon is actually deliveredin an insulin-only system, G_(c) has no effect on glucose insofar astreating or preventing low glucose levels, which in turn is generallyexpected to invoke further computed glucagon dosing (e.g., goes towardsincreasing the magnitude of G_(d) for a given situation). By contrast,since G_(d) is delivered in a bihormonal system, it is expected to havean effect in preventing or reducing the frequency, extent, or durationof low glucose levels, which in turn is expected to limit the overallmagnitude of glucagon dosing (e.g., limits G_(d) for a given situation).As such, for a given set of dependencies, it is generally expected thatG_(c)>G_(d) between the two system configurations. Likewise, since G_(c)has no effect in combating low glucose levels while G_(d) does have suchan effect, it is expected that treatment carbohydrates C_(io)>C_(bh),when comparing the two system configurations.

If one can ideally relate, for a given real-use case of an insulin-onlysystem with Gc, what the corresponding C_(io) would have been for thesame real-use scenario, had the computed online glucagon dosing actuallybeen delivered as G_(d), one can project an estimate that the user wouldhave required “C_(io)−C_(bh)” less treatment carbs (e.g., would havesaved that much), had they instead been using a bihormonal system (withthe same insulin controller), where glucagon would have been delivered.Conversely, if one can ideally relate, for a given real-use case of abihormonal system with G_(d), what the corresponding C_(bh) would havebeen for the same real-use scenario, had the delivered online glucagondosing not been delivered but only computed as G_(c), one can project anestimate that the user had actually avoided the need to take“C_(io)−C_(bh)” additional treatment carbs, had they been instead usingan insulin-only system (with the same insulin controller), whereglucagon would not have been delivered. It should be understood that theabove calculations are an estimate in an ideal situation as, inpractice, it is not possible to have a re-run of a past real-usescenario to obtain such ideal relationships.

For practical implementation, real-use cases where the insulin-onlysystem is used can be re-simulated while assuming a bihormonal system isavailable, where glucagon is assumed to be delivered. Since the controlsystem may take delivered doses into account when issuing subsequentnearby glucagon doses, the simulated glucagon dosing may exhibit areduction relative to the original G_(c) of the insulin-only system.With the glucose profile kept unaltered in a simulation, the simulationmay lack reflecting any resulting glucose excursions in response to theassumed delivered glucagon dosing. The simulation in turn may lackreflecting the full reduction in glucagon dosing down to G_(d) that mayhave been observed if the glucose excursions had in fact benefited fromglucagon being delivered. Thus, the reduced glucagon dosing that isobserved in the simulation, pseudo delivered glucagon Ĝ_(d), mayarguably be exaggerated in magnitude relative to what would have beenthe “real G_(d)”. As described above, based on prior analyses G_(c) canbe mapped to a corresponding amount C_(io) in the insulin-onlyconfiguration, and Ĝ_(d) can be mapped to a corresponding amount Ĉ_(io)in the bihormonal configuration. The simulation results, therefore, canmap the reduction “G_(c)−Ĝ_(d)” to an estimate “C_(io)−Ĉ_(bh)” oftreatment carbs that the user would spare had they been using thebihormonal system. The estimates may be conservative estimates.Repeating the simulation analyses across a variety of real-use casesthat span the range of G_(c) observed in practice provides a globalmapping between them and the associated range of (in some cases,conservative) estimates “C_(io)−Ĉ_(bh)” of treatment carbs that the userwould likely not need to consume had they been using the bihormonalsystem. Conversely, the mapping can be utilized when a bihormonal systemis being used, where the observed dosing G_(d) is mapped back to apseudo glucagon Ĝ_(c) and the resulting associated difference“Ĉ_(io)−C_(bh)” provides a (in some cases, conservative) estimate of thetreatment carbs that the user had likely saved by virtue of being on thebihormonal system.

Certain embodiments includes a system that comprises a controller forautomatic control of a blood glucose level of a subject. The controllermay be operative to generate an insulin dose control signal based ontime-varying glucose levels of the subject as represented by a glucoselevel signal over time. The glucose level signal can be generated by aglucose sensor operative to continually sense a glucose level of thesubject. The insulin dose control signal may control the delivery ofdoses of insulin by a delivery device. Further, the controller canoperate at a regular frequency to generate an insulin dose controlsignal to regulate the glucose levels in the subject. During onlineoperation, the controller can employ a control algorithm that generatesa glucagon dosing signal, which may be mapped to an associated amount oforal carbohydrates.

The oral carbohydrates may be associated with the prevention ortreatment of low glucose levels. Further, the mapping between theglucagon dosing signal and the oral carbohydrates may be derived fromanalysis of clinical data. The glucagon dosing signal may be computed,but not delivered in an insulin-only system configuration. In contrast,the glucagon dosing signal can be computed, and glucagon can bedelivered in an insulin-glucagon system configuration. The computedglucagon dosing in an insulin-only system configuration can be mapped toan amount of oral carbohydrates that is estimated to have been saved hadglucagon dosing been delivered if an insulin-glucagon systemconfiguration had instead been used. The delivered glucagon dosing in aninsulin-glucagon system configuration can be mapped to an amount of oralcarbohydrates that is estimated to have been saved if an insulin-onlysystem configuration had instead been used. The mapping may be dependenton the clinical properties of the insulin and glucagon being used, andsettings in the control system related to the action and effect ofinsulin and glucagon. Further, the mapping may be dependent on thesubject's body mass.

Backup Therapy Protocol Generation

An ambulatory medicament device, such as a glucose level control system(e.g., an insulin pump or a combined insulin and counter-regulatoryagent (e.g., Glucagon) pump), can provide personalized therapy to asubject. In other words, the ambulatory medicament device may providemedicament that is specific to a subject's physiology, condition,activity, and the like. Further, some ambulatory medicament device'smonitor a condition of the subject to determine when to provide therapy,what type of therapy to provide (e.g., insulin or counter-regulatoryagent therapy), and/or how much therapy to provide. The therapy providedby the ambulatory medicament device may be ongoing and, in some cases,lifesaving. Thus, it is important that ambulatory medicament devicefunction uninterrupted.

Despite best efforts, sometimes therapy by the ambulatory medicamentdevice is interrupted. For example, the ambulatory medicament device maybreak, a subject may run out of or not have access to a necessarydisposable (e.g., a replacement insulin cartridge, a site kit forchanging the site of the ambulatory medicament device, a replacementbattery, and the like), or the subject may forget to charge a battery ofthe ambulatory medicament device or not be in a location where a powersource is available to charge the ambulatory medicament device. Thus,there are occasions when the ambulatory medicament device may not beavailable or may need replacing.

When the ambulatory medicament device is not available, or when areplacement (temporary or permanent) ambulatory medicament device isbeing used, it may be desirable to have an indication of the therapysettings from the ambulatory medicament device. For example, if a user(e.g., a subject, healthcare provider, parent, or guardian) is providingalternative therapy (e.g., injection therapy) while the ambulatorymedicament device, it may be necessary to know the quantity of therapyto provide under particular circumstances or at particular times.

In some cases, a healthcare provider may have access to therapyinformation that may have been previously determined, for example, viaclinical testing. This therapy information may include any type ofinformation that can be used to determine therapy to provide to asubject at a particular time or under particular conditions. Forexample, the therapy information may indicate a setpoint insulin rangefor the subject, a quantity of insulin to provide to the user to adjustglucose levels, an amount of time for insulin to reach max concentrationin the subject, or any other information that might impact the timing oramount of dosing of a medicament.

The therapy information available to the healthcare provider may beinsufficient. For example, the subject may not be able to reach thehealthcare provider to obtain the therapy information at a point in timewhen the information is needed. Further, in some cases the informationmay be outdated because, for example, the ambulatory medicament devicemay have refined the therapy over time. If the refinements have occurredrecently, it is possible that the outdated values of the healthcareprovider may be sufficient until a replacement ambulatory medicamentdevice can repeat the refinement process of the original ambulatorymedicament device. In other cases, the outdated therapy information maybe insufficient because, for example, the refinements were significantor the subject may have had physiological changes (e.g., weight gain orweight loss, or metabolism changes) since the last time a clinical testwas performed. Using outdated therapy information may be less effectiveand may cause discomfort or harm to a subject.

Certain embodiments of a system disclosed herein can generate backuptherapy data. Using the backup therapy data, a subject (or user) canperform injection therapy or configure a replacement ambulatorymedicament device if the subject's current device malfunctions. By usingthe backup therapy data, the subject can maintain a level of therapycare that matches or more closely matches what was being provided by theambulatory medicament device than clinical data, which may be outdatedif available at all.

The system can include an automated glucose level control system (e.g.,the glucose level control system 5802) configured to generate a backuptherapy protocol comprising insulin therapy instructions derived fromautonomously determined doses of insulin. During normal operation, thesystem may receive glucose level signals from a sensor operativelyconfigured to determine glucose levels in a subject. The sensor caninclude any type of sensor that can determine glucose levels. Forexample, the sensor may be a Continuous Glucose Monitoring (CGM) sensor.

Using the determined glucose levels, the system may autonomouslydetermine and/or generate a dose control signal using a controlalgorithm. The determination and/or generation of the dose controlsystem may be performed without any user action or interaction with theglucose control signal. In some cases, the lack of user action orinteraction with the glucose level control system refers to consciousaction and may exclude sensor measurements of physiologicalcharacteristics of the subject. The control algorithm may autonomouslydetermine doses of insulin to be infused into the subject for thepurpose of controlling blood glucose of the subject based at least inpart on the glucose level signal. The control algorithm may include anytype of control algorithm.

For example, the control algorithm may be a bi-exponentialpharmacokinetic (PK) model that models the accumulation of insulin dosesin the blood plasma of the subject. The automated blood glucose systemmay control delivery or administering of insulin or a counter-regulatoryagent based on the bi-exponential PK model and one or more blood glucosemeasurements of the subject. The bi-exponential PK model may model theabsorption of subcutaneously administered insulin into blood and/or arate of diminishing glucose in the blood. The bi-exponential PK modelover time may be represented by the following equation:

p(t)=KU ₀(e ^(−α) ¹ ^(t) −e ^(−α) ² ^(t))  (1)

where U₀ is the subcutaneous dose in units (U), K is a scaling constant,and α₁ and α₂ are time constants.

As an alternative example, the control algorithm may include a linearalgorithm that models diminishing glucose or the accumulation of glucosein the subject based on a linear reduction rate. For example, thecontrol algorithm may determine that a particular dose, D, of insulin isto be administered to the subject. The control algorithm may thenestimate that 0.25*D of the insulin is absorbed into the blood plasmaper hour over 4 hours. Similarly, the control algorithm may estimatethat the insulin diminishes at a rate of 0.33*D per hour over threehours upon the insulin reaching maximum concentration within the bloodplasma.

Regardless of the control algorithm used, the automated glucose levelcontrol system may administer insulin and, in some cases, acounter-regulatory agent one or more times over a particular timeperiod. There may be multiple reasons and/or triggers that cause theautomated glucose level control system to supply insulin. For example,the automated glucose level control system may provide a basal does ofinsulin on a periodic basis in an attempt to maintain a steady bloodglucose level in the blood plasma of the subject. As another example,the automated glucose level control system may supply mealtime bolusesof insulin to account for an expected amount of glucose to be consumedas part of a meal. The mealtime bolus may be an amount specified by auser or may be an amount of insulin administered in response to anindication of meal size by the subject. This indication of meal size maybe subjective. In some cases, the size of the bolus of insulin for anidentified meal size may be a fixed or constant value. In some othercases, the size of the bolus of insulin for an identified meal size mayvary over time as the automated glucose level control system learns orrefines the amount of insulin to administer to a subject to keep thesubject's blood glucose within a target setpoint. The automated glucoselevel control system may learn or refine the optimal insulin toadminister based on a comparison of expected blood glucose levelmeasurements to actual blood glucose level measurements when the subject(or other user) makes a subjective identification of meal size. Inaddition to basal and mealtime boluses of insulin, the automated glucoselevel control system may also supply correction doses of insulin to thesubject based on the glucose level signal. The correction doses ofinsulin may be supplied in response to a model predictive controller(MPC) determining or estimating that a user's level of insulin isexpected to fall below a threshold in some future period of time basedon blood glucose level readings. The MPC may execute a control algorithmthat can regulate glucose concentration to a reference setpoint whilesimultaneously minimizing both the control signal aggressiveness andlocal insulin accumulation. A mathematical formulation describing thesubcutaneous accumulation of administered insulin may be derived basedon nominal temporal values pertaining to the pharmacokinetics of insulinin the subject. The mathematical formulation may be in terms of theinsulin absorption rate, peak insulin absorption time, and/or overalltime of action for the insulin (or another medicament). Examples of anMPC controller that may be used with embodiments of the presentdisclosure are described in U.S. Pat. No. 7,806,854, issued on Oct. 5,2010, the disclosure of which is hereby incorporated by reference in itsentirety herein for all purposes.

The automated glucose level control system may track insulin therapyadministered to the subject over a tracking period. Although thetracking period is not limited in length and may generally be any periodof time, typically the tracking period is at least a minimum period oftime sufficient for the automated glucose level control system to learnor refine the amount of medicament (e.g., insulin) to administer to thesubject under particular conditions (e.g., when particular blood glucoselevels are detected or when particular meal sizes are identified). Forexample, the automated glucose level control system may initiallyadminister 6 units of insulin for lunch and 10 units of insulin fordinner. These initial values may be set be a healthcare provider and/ora subject based, for example, on clinical data for the subject. However,over time (e.g., 3-5 days), the automated glucose level control systemmay determine that providing 7 units of insulin for lunch and 8 units ofinsulin for dinner maintains the subject's blood glucose level closer tothe median of the setpoint range than did the initial configuration.Although not limited as such, generally each unit of insulin is1/100^(th) of a milliliter of insulin.

As indicated, the tracking period can be any length of time. Forexample, the tracking period could be 1 day, 3 days, 5 days, 7 days,anything in between, or more. Typically, the tracking period is at leastlong enough to provide sufficient time to learn or refine initialsettings of the automated glucose level control system for the subject.In some cases, the tracking period may be 1 or 2 days. In other cases,the tracking period may be from a particular time period until a currenttime period. For example, the tracking period may be from the start oftherapy until a current point in time. In other cases, the trackingperiod may be a moving or shifting window. For example, the trackingperiod may be the least week, two weeks, month, or year. Further, fornon-blood glucose systems, the tracking period may differ based on theamount of time sufficient to determine or refine medicament controlvalues for the subject. In some cases, the tracking period may a windowof a particular length. This window may be a moving window. For example,the window may be the previous 7 days. As time passes, the window movesto continue to encompass the previous 7 days.

Tracking the insulin therapy may include storing the autonomouslydetermined doses of insulin delivered to the subject. These autonomouslydetermined doses of insulin may include one or more of basal insulindoses, mealtime insulin boluses, or correction insulin doses. Moreover,tracking the insulin therapy may including tracking the type of insulinused. The type of insulin may include any type of insulin, such asfast-acting insulin (e.g., Lispro, Aspro, or Glulisin), regular orshort-acting insulin (e.g., Humulin R, Novolin R, or Velosulin R),intermediate-acting insulin (e.g., Humulin N, Novolin N, ReliOn),long-acting insulin (e.g., detemir (Levemir), and glargine (Basaglar,Lantus)), or Ultra long-acting insulin (e.g., degludec (Tresiba),glargine u-300 (Toujeo)). Further, tracking the insulin therapy mayinclude tracking counter-regulatory agent (e.g., Glucagon) therapy.

In some cases, tracking the insulin therapy may include calculatingaverage therapy provided over a period of time (e.g., over the trackingwindow). For example, the tracking the insulin therapy may includedetermining a moving average of the past 7 days of nominal basal dosesduring each dosing interval. Assuming basal therapy is provided everyfive minutes, the moving average may be calculated based on the previous288 doses (e.g., over 1 day) or 2016 doses (e.g., over 7 days). Thiscalculation can be used to obtain a basal rate profile for backuptherapy. In some cases, the time period may be broken up into differenttime segments that may be associated with different rates of therapy.For example, there may be 4 basal therapy periods (e.g., 10 pm-4 am, 4am-10 am, 10 am-4 pm, and 4 pm-10 pm). Thus, a separate moving averagemay be calculated for each of the basal therapy periods over a day, orover some other time period (e.g., 7 days). The calculated averages maybe used to calculate a backup basal rate that can be used to program anautomated glucose level control system. Further, the basal rate profilemay include aggregating the doses across the day to determine a dose oflong-acting insulin that can be used for injection therapy.

Similar to the basal therapy, a moving average of correction doses canbe calculated to determine a correction bolus of insulin to supply via apump or injection therapy. Alternatively, or in addition, the movingaverage of correction doses in combination with measurements of bloodglucose of the subject over time may be used to determine a rate ofchange of blood glucose from a unit of insulin provided duringcorrection therapy.

Mealtime boluses may also be calculated using a moving average. Further,a separate moving average may be calculated for each meal (e.g.,breakfast, lunch, and dinner) dose over some period of time (e.g., 7previous days of mealtimes). In some cases, each of the moving averagesmay be calculated using different windowing functions. For example, themoving average may be calculated using a Hann window or a Hammingwindow. In some cases, different levels of dosing may be determined fordifferent meal sizes and different doses may be determined for differentmeals. In some cases, different meals (e.g., breakfast vs lunch) mayhave different dosing despite similarity in size due, for example, todifferences in the subject's blood glucose levels when they wake upversus when they usually have lunch, or because differences in types offoods consumed at breakfast versus lunch. Further, in some cases,differences in metabolisms of different subjects may result in differentmealtime boluses.

The insulin therapy may be stored in a therapy log, or any other type ofdata structure. Further, the insulin therapy may be stored in a memoryof the automated blood glucose system, on a companion device, on acomputing device of the subject or user (e.g., a laptop or desktop), ina cloud computing environment, or in any other storage system capable ofreceiving the insulin therapy information from the automated glucoselevel control system.

Using the therapy log or tracked insulin data, the automated bloodglucose system, or a computing system with access to the therapy log ortracked insulin data, may generate a backup insulin therapy protocol.The backup insulin therapy protocol may include a backup injectiontherapy protocol or a backup pump therapy protocol. The backup injectiontherapy protocol may include one or more amounts of insulin (or othermedicament) to administer using injection therapy (e.g., manuallyprovided shots) at one or more times to help maintain the subject'scondition within a normal or desired physiological range or condition.The backup pump therapy protocol may include data and/or instructionsfor a replacement medicament pump of the same type or of a differenttype to supply therapy to the subject. The replacement medicament pumpmay be a permanent replacement or a temporary replacement.

The backup pump therapy protocol may be the same as and/or include thesame type of information as the backup injection therapy protocol.Alternatively, or in addition, the backup pump therapy protocol mayinclude different values than the backup injection therapy protocol. Forexample, the backup pump therapy protocol may include an indication ofbasal therapy to provide periodically on relatively short increments(e.g., every 5 minutes, every half hour, every hour, etc.). Because aninsulin pump may automatically administer insulin, it is possible toprovide a steady or periodic drip of insulin. It may be impractical fora subject using injection therapy to administer insulin manually onsimilar short increments. Instead, a user might administer therapy on aless regular basis (e.g., once every roughly 4-5 hours or 6-8 hours,prior to mealtimes, after waking, and/or before sleeping, etc.).Accordingly, the backup therapy protocol for a pump and for injectionmay differ. Further, the type of insulin used or identified in thebackup protocol may differ. For example, the backup protocol may callfor use of long-acting insulin, such as, for example, insulin glargine,or intermediate-acting insulin, such as, for example human recombinantinsulin.

In some cases, the backup pump therapy protocol may be used to manuallyrefine pump settings for a replacement glucose level control system tobe used by the subject. In other cases, the replacement glucose levelcontrol system may automatically configure itself based on the backuptherapy protocol. For example, a user may cause the backup therapyprotocol to be provided to the replacement glucose level control system,which may use the information to self-calibrate.

Regardless of whether a backup protocol is generated or needed,collecting and analyzing therapy data for therapy provided by theautomated glucose level control system can be useful for helping tomanage a subject's condition. For example, therapy data may be useful indetermining whether the subject is satisfied with therapy provided bythe automated glucose level control system or whether the glucose levelcontrol system is configured in a way that best matches the subject'slifestyle or therapy preferences (subjective or otherwise). One way todetermine whether the glucose level control system is providing desiredtherapy, or therapy at a desired rate, is to determine the frequencyand/or magnitude of modifications made by the subject, or other userthat may help manage a subject's therapy, to therapy provided by theautomated glucose level control system.

The automated glucose level control system disclosed herein can trackuser modifications to a control parameter over a tracking period. Thetracking period may include any time period described above for trackingtherapy to generate a backup protocol. Further, the control parametermay include any type of control parameter that may affect theadministering of therapy. For example, the control parameter may relateto a quantity of therapy, a timing of delivered therapy, a rate thattherapy is delivered, or a trigger of when or whether to delivertherapy, among other control parameters. Moreover, the controlparameters may directly affect the delivery of therapy (e.g., specify atime to deliver the medicament or a quantity of medicament to deliver)or may indirectly affect therapy (e.g., adjust a setpoint range tomaintain blood glucose or a rate of insulin accumulation in the subject,which may be used to modify a control algorithm for administeringtherapy).

The user modifications may include any change to the control parameteror settings of the automated glucose level control system. For example,the automated glucose level control system may track each instanceand/or the rate or percentage of times a user reduces or increases acontrol parameter (e.g., an amount of administered insulin). Further,tracking changes to the control parameter may including tracking howoften a user pauses therapy or temporarily adjusted a target bloodglucose range, or other control parameter. In addition, tracking changesto the control parameter may include tracking when a user makes changesto the control parameter. For example, the user may generally modify thecontrol parameter at night, but leave the daytime parameter unchanged,or vice versa. In some cases, the automated glucose level control systemmay track a subject's weight over time. The weight may be provided by auser and may affect the glucose control (e.g., an amount of insulinadministered may be related to a subject's weight).

The automated glucose level control system may generate a report thattracks user modifications to the control parameter. The report maycomprise a measure of the frequency of increases and decreases from thestored control parameter value. Further, the report may include anindicator of a percentage of times a user modified a control parameterhigher or lower than the stored control parameter value of the automatedglucose level control system over the tracking period. In some cases,the report indicates the number of times that the infusion of insulin ispaused over the tracking period, or the speed (e.g., aggressiveness)that insulin is delivered to the subject.

Using this report, a clinician or other healthcare provider candetermine whether modifications should be made to a control parameter tobetter manage a subject's therapy. For example, if it is determined thata subject is raising a blood glucose target level 4-5 times a weekduring an evening time or nighttime, the clinician may determine thatthe target setpoint for the evening should be adjusted to reduce thenumber of occurrences that a user manually adjusts therapy, or controlparameter settings for therapy, provided by the automated glucose levelcontrol system. In some cases, the subject may be adjusted therapy basedon subjective reasons. In some such cases, the therapy report may enablethe clinician or healthcare provider to train the subject on controllinghis or her disease. In other cases, the clinician may determine that thesubject has a different tolerance for blood glucose than initiallydetermined or than an average subject and may adjust one or more controlparameters of the automated glucose level control system accordingly.

In some implementations, the automated glucose level control system mayautomatically adjust one or more control parameters over time based onthe report. For example, if the automated glucose level control systemdetermines that over a course of a month the subject adjusted lower adaytime target glucose range 20 out of 30 days, the automated glucoselevel control system may modify a control parameter to have a lowersetpoint range. In some cases, the automated glucose level controlsystem may communicate the change to a user, such as the subject, aparent or guardian, or a healthcare provider.

Example Backup Therapy Protocol Generation Process

FIG. 61 presents a flowchart of an example backup therapy protocolgeneration process 6100 in accordance with certain embodiments. Theprocess 6100 may be performed by any system that can track medicamenttherapy (e.g., insulin therapy) provided to a subject over time andgenerate a backup therapy protocol that may be used if a glucose levelcontrol system 5802 becomes unavailable. For example, the process 6100may be performed by one or more elements of the glucose level controlsystem 5802. In some cases, at least certain operations of the process6100 may be performed by a separate computing system that receivesindications of medicament therapy provided to the subject 5804 from theglucose level control system 5802. Although one or more differentsystems may perform one or more operations of the process 6100, tosimplify discussions and not to limit the present disclosure, theprocess 6100 is described with respect to particular systems.

The process 6100 begins at block 6102 where the glucose level controlsystem 5802 receives a glucose level of a subject 5804. Receiving theglucose level may include receiving and/or determining a glucose levelsignal corresponding to a glucose level of the subject. The glucoselevel signal may be received from the glucose sensor 5808 (e.g., a CGMsensor). Alternatively, or in addition, the glucose level may bereceived from a user that provides the glucose level to the glucoselevel control system 5802 via a user interface, such as a user interfacegenerated by the processor 5820 that may be output on a touchscreen by atouchscreen controller 5828. The glucose level received from the usermay be a glucose level measured using an alternative sensor ormeasurement mechanism (e.g., diabetes measurement strips) that may beused in place of the glucose sensor 5808.

At block 6104, the glucose level control system 5802 generates aninsulin dose control signal based at least in part on the glucose levelsignal. In some cases, the insulin dose control signal may be amedicament control signal configured to control a medicament pump toadminister medicament (e.g., insulin, counter-regulatory agent, or othermedicament) to a subject 5804. The dose control signal may be generatedusing a control algorithm configured to autonomously determine doses ofinsulin to be administered to or infused into the subject for thepurpose of controlling blood glucose of the subject based at least inpart on the glucose level or glucose level signal determined at theblock 6102.

At block 6106, the glucose level control system 5802 tracks insulintherapy administered to the subject 5804 over a tracking period. Thetracking period is typically at least one day and may be longer. Forexample, the tracking period may be 1 day, 2 days, a week, a month,several months, a year, any length of time between the foregoingexamples, or even longer. In some cases, the tracking period may becontinuous from a point in time when tracking begins. For example, thetracking period may encompass the entire usage lifetime of the glucoselevel control system 5802 by the subject 5804. In cases where thetracking period is set for a defined period of time (which may bemodified for different iterations of the process 6100), the process 6100may be repeated periodically, upon request, or upon a triggering eventusing a new tracking period, of equal or different length. Thetriggering event may include any event that may render a prior generatedbackup therapy protocol potentially out-of-date. For example, thetriggering event may include a change in medicament type (e.g.,different insulin or counter-regulatory agent formulations), a change inphysiological characteristics of the subject 5804 (e.g., a change inweight, or sensitivity to different glucose levels or medicament), or achange in average activity level of the subject 5804.

Although the tracking period is typically at least one day enabling theglucose level control system 5802 to determine a backup protocol basedon data from a full cycle (e.g., waking and sleeping hours) of glucoselevel control system 5802 use, in some cases, the tracking period may atleast initially be less than a day. For example, an initial backuptherapy protocol may be generated after a half-day's activity. Thisinitial backup therapy protocol may be updated as more data becomesavailable throughout the day's (and, in some cases, subsequent day's)use of the glucose level control system 5802.

In some cases, the tracking period may be defined by or based on aparticular number of insulin administering events. For example, thetracking period may be defined by at least ten instances of generatingan insulin dose based on a glucose level signal. As another example, thetracking period may be defined by a minimum number of meal events,correction dose events, and/or basal dose events. For instance, thetracking period may require 3 meals, or 3 meals of each meal type tooccur, 2 correction doses, and/or 100 basal doses. It should beunderstood that the aforementioned number of doses is just an example,and the tracking period may include more or fewer dose amounts.Moreover, the tracking period may be defined or specified as acombination of time and occurrences of a particular number of doses ofinsulin.

In some cases, the tracking period may be variable. For example, if theglucose level control system 5802 determines that the insulin dosetherapy is inconsistent or erratic over the tracking period (e.g., dueto inconsistent exercise or eating habits), the tracking period may beextended.

Tracking the insulin therapy may include storing the insulin dosecontrol signal generated based at least in part on the glucose levelsignal at the block 6104. Alternatively, or in addition, tracking theinsulin therapy may include storing an indication of a quantity ofinsulin (or other medicament) corresponding to the insulin (or anothermedicament) dose control signal. The insulin dose control signal and/orthe indication of the quantity of insulin may correspond to a dose ofinsulin delivered to the subject 5804 as a basal insulin dose, acorrection bolus of insulin, and/or as a mealtime bolus of insulin.

Storing the insulin dose control signal and/or the indication of thequantity of insulin may include storing the insulin dose control signaland/or the indication of the quantity of insulin in a therapy log or anyother type of data structure in the memory 540 of the glucose levelcontrol system 5802. Alternatively, or in addition, the glucose levelcontrol system 5802 may store the insulin dose control signal and/or theindication of the quantity of insulin at a remote data store. Thisremote data store may be a local computing system with which the glucoselevel control system 5802 may communicate (e.g., a laptop, desktop,smartphone, or other computing device of the subject 5804 or a user).The glucose control system 5802 may provide the insulin dose controlsignal data or the indication of the quantity of insulin to the localcomputing system via Bluetooth® or other near field communicationservices, or via a local network. Alternatively, or in addition, theremote data store may be a remote computing system that the glucoselevel control system 5802 may communicate with over a wide area network,such as a wireless area network, a cellular network using IoT basedcommunication technology, cellular communication technology, or anyother communication network. In some cases, the wide area network mayinclude the Internet. The glucose level control system 5802 may includea wireless radio that enables it to communicate with the local or remotecomputing system. Further, the remote computing system may be acomputing system of a data center or a cloud computing environment.

Whether a local or remote computing system, the glucose level controlsystem 5802 may establish a communication channel with the computingsystem. This communication channel may be an encrypted channel. Furtherthe communication channel may be a direct end-to-end connection betweenthe glucose level control system 5802 and the computing system. Once thecommunication channel is established, the glucose level control system5802 may transmit the insulin dose control signal data or the indicationof the quantity of insulin to the computing system.

Generally, the operations associated with the blocks 6102-6106 may berepeated multiple times throughout the course of the tracking period.For example, in some cases, an insulin dose control system associatedwith basal insulin may be generated up to 288 times a day. Accordingly,tracking the insulin therapy may include storing insulin does controlsignals and/or corresponding indications of quantities of insulin for aplurality of autonomously determined doses of insulin infused into thesubject 5804 throughout the tracking period.

Generally, counter-regulatory agent therapy includes administering acounter-regulatory agent (e.g., glucagon) when there is a risk oroccurrence of hypoglycemia. Usually, the counter-regulatory agent is notsupplied on periodic or daily basis. However, it can be useful tounderstand the amount and frequency that counter-regulatory agent isadministered to the subject 5804. For example, it may help a healthcareworker or user guide or adjust care for the subject 5804. Further,tracking counter-regulatory agent use may help determine a minimumquantity of counter-regulatory agent that should be accessible to thesubject 5804, either in a bi-hormonal pump or for use in injectiontherapy. In some cases, the block 6106 may include tracking thecounter-regulatory agent administered during the tracking period.Tracking the counter-regulatory agent therapy may include storing anindication of autonomously determined doses of counter-regulatory agentdelivered to the subject 5804 responsive to the glucose level signalobtained at the block 6102.

At block 6108, the glucose level control system 5802 generates a backuptherapy protocol based at least in part on the tracked insulin therapy.The backup therapy protocol may be determined based on an averagequantity or rate of insulin administered to the user over the trackingperiod, over different portions (e.g., breakfast, lunch, and dinner, orwaking and sleeping hours, etc.) of the tracking period, or in responseto particular events (e.g., when eating, when blood glucose levelexceeds a threshold level, etc.). The backup therapy protocol mayinclude a backup injection protocol and/or a backup pump therapyprotocol. The backup injection protocol may provide a user (e.g., thesubject 5804, a parent or guardian, or other caretaker for the subject5804) with quantities of insulin that may be administered to the subject5804 via injection. Further, the backup injection therapy may indicatetimes that the insulin may be administered. For example, the backupinjection therapy may indicate quantities of insulin to be administeredat particular mealtimes. Further, the backup injection therapy mayindicate an effect that a unit of insulin may have on the subject 5804enabling a user to calculate how much insulin to administer to thesubject 5804 when a blood glucose reading indicates that the glucoselevel of the subject 5804 is too high (e.g., above a desired setpointrange).

Similar to the backup injection therapy protocol, the backup pumptherapy protocol may provide a user (e.g., the subject 5804, a parent orguardian, or other caretaker for the subject 5804) with quantities ofinsulin that may be administered to the subject 5804 via a medicamentpump. Using the backup pump therapy protocol, a user may configure themedicament pump to administer the quantities of insulin identified. Thebackup pump therapy protocol may be used to configure the medicamentpump when access to a CGM sensor is unavailable (e.g., the subject 5804does not possess a CGM sensor, or the medicament pump or CGM sensor hasa fault, etc.). Further, the backup pump therapy protocol may be usefulfor providing an initial configuration to a replacement glucose levelcontrol system.

In some cases, the backup injection therapy protocol and the backup pumptherapy protocol may be the same. However, often at least therecommended basal therapy settings may differ. It is generally notpracticable for insulin to be administered to a subject 5804 more than afew times a day via injection therapy. Thus, the backup injectiontherapy protocol may identify long acting insulin units or doses thatmay be administered on a limited basis (e.g., once or twice a day).However, the medicament pump may more easily administer insulin on amore than limited basis (e.g., every hour, every half hour, every 5minutes, etc.). Thus, the backup pump therapy protocol may identify abasal rate of insulin that may be administered once every time unit(e.g., once per hour or once per 15 minutes, or once per five minutes),or continuously at a particular rate (e.g., 0.5 or 0.6 units) per timeunit (e.g., per hour). Moreover, the backup pump therapy protocol mayidentity different rates for different portions of a day (e.g., one rateeach half of the day, one rate each quarter of the day, or one rateduring typical waking hours and one rate during typical sleeping hoursfor the subject, etc.).

In some cases, an initial backup therapy protocol may be generated atthe block 6108. The initial backup therapy protocol may be updated overtime as additional insulin therapy data is obtained.

Generating the backup therapy protocol may include determining a numberof long acting insulin units based at least in part on an average totalbasal insulin provided to the subject 5804 per day over the trackingperiod. The average total basal insulin provided per day may be includedin a backup injection therapy protocol as a single dose of long actinginsulin that is configured to help maintain the basal insulin level ofthe subject 5804 throughout the day. In some cases, the averaged totalbasal insulin provided per day may be included in a backup injectiontherapy protocol as multiple doses of insulin (e.g., 2 or 3 dosesthroughout the day).

Alternatively, or in addition, the basal insulin may be included in thebackup therapy protocol, such as in a backup pump therapy protocol, as adosage rate that may be supplied to a pump to provide a rate of basalinsulin throughout the day. Further, in some cases, each day of thetracking period may be divided into a plurality of sub-periods. Forexample, each day of the tracking period may be divided into two, three,four, or more time periods, or equal or different length. In some suchcases, generating the backup therapy protocol may include determining anhourly basal rate for each sub-period of the plurality of sub-periods.This hourly basal rate may be determined by averaging the correspondingsub-periods for each day of the tracking period. For example, if eachday of the tracking period is divided into two sub-periods (e.g., noonto midnight, and midnight to noon), the basal rate supplied during thefirst sub-period throughout the tracking period may be averaged and thebasal rate supplied during the second sub-period throughout the trackingperiod may be averaged to determine two basal rates for inclusion in thebackup therapy protocol. The basal rate may be determined on an hourlyrate or based on any other time period. Alternatively, the basal ratemay be determined based on an amount of time that a particular quantity(e.g., one unit) of insulin is recommended to be administered to thesubject 5804 as part of the backup therapy protocol. For example, if theglucose level control system 5802 determines that the subject 5804 isreceiving one unit of insulin every 1.125 hours, the backup therapyprotocol may indicate the basal rate to be one unit every 1.125 hours.Alternatively, or in addition, the backup therapy protocol may indicatea basal rate of 0.89 units per hour.

In addition, generating the backup therapy protocol may includedetermining an average correction bolus provided to the subject per dayover the tracking period. The average correction bolus may be determinedby adding the total amount of correction doses administered each dataand dividing by the number of days in the tracking period. The averagecorrection bolus may be included in the backup therapy protocol asguidance for the user. However, generally, the correction bolus issupplied in response to a determination that a subject's blood glucoselevel is spiking or exceeding a threshold, and not necessarily as adaily dose of insulin. Accordingly, the average correction bolus may beincluded as part of the backup therapy protocol to facilitate the userunderstanding an amount of insulin that is likely to be required duringan average day, which may be useful for the user (e.g., the subject) todetermine how much insulin to have accessible to use, for example, ininjection therapy. In some cases, one or more days, or time periods, ofthe tracking period may be omitted when determining the averagecorrection bolus because, for example, the one or more days or timeperiods may be determined to be outliers. The outliers may be omitted toprovide a more accurate understanding of average insulin needs orconsumption.

In some implementations, the glucose level control system 5802 maydetermine an average change in blood glucose at least partiallyattributable to a unit of insulin provided as a correction bolus to thesubject during the tracking period. In some cases, the glucose levelcontrol system 5802 may correlate each correction bolus applied duringthe tracking period to a change in the blood glucose level of thesubject 5804.

Generating the backup therapy protocol may include determining, for eachmealtime of a plurality of mealtimes per day, an average mealtime bolusof insulin provided to the subject over the tracking period. In somecases, the average mealtime bolus may be determined for particular meals(e.g., breakfast, lunch, and dinner), while other periods of food intake(e.g., snacks or teatime) may be omitted or ignored. Further, theaverage mealtime boluses may be associated with particular meal sizes asidentified by a user. For example, the glucose level control system 5802may determine an average mealtime bolus for a small and a large meal, orfor a small, a medium, and a large meal. The average mealtime bolus maybe determined by averaging an amount of insulin the glucose levelcontrol system 5802 determines should be administered to the subject5804 using a control algorithm of the glucose level control system 5802for each mealtime and identified meal size.

In some cases, the backup therapy protocol may include data relating tothe administering of counter-regulatory agent. For example, the backuptherapy protocol may include an indication of total counter-regulatoryagent and/or daily counter-regulatory agent provided to the subject overthe tracking period.

At block 6110, the glucose level control system 5802 outputs the backuptherapy protocol. Outputting the backup therapy protocol may includedisplaying the backup therapy protocol on a display enabling a user toimplement the backup therapy protocol. Alternatively, or in addition,outputting the backup therapy protocol may include transmitting thebackup therapy protocol to a computing device of a user for displayand/or storage. In some cases, the backup therapy protocol may be storedat the glucose level control system 5802 and may be accessed in responseto a user interaction with a user interface of the glucose level controlsystem 5802.

In some cases, the process 6100 can be combined at least in part withthe process 6200 described below. Thus, in some cases, the backuptherapy protocol may further include a record of user modifications toone or more control parameters used by the control algorithm of theglucose level control system 5802 to autonomously determine doses ofinsulin to be infused into or administered to the subject. This recordof user modifications may include an identity of instances of usermodification to the control parameter and/or a percentage of times auser modified the control parameter during each day of the trackingperiod and/or during the entire tracking period.

FIG. 62 presents a flowchart of a control parameter modificationtracking process 6200 in accordance with certain embodiments. Theprocess 6200 may be performed by any system that can track userinteractivity with glucose level control system 5802, and morespecifically, occurrences of a user modifying a control parameter usedby the glucose level control system 5802 to help control medicamentdelivery to the subject 5804. For example, the process 6200 may beperformed by one or more elements of the glucose level control system5802. In some cases, at least certain operations of the process 6200 maybe performed by a separate computing system that receives indications ofchanges to control parameter settings of the glucose level controlsystem 5802 from the glucose level control system 5802 and/or from userinteraction with a user interface at the separate computing system priorto transmitting the modification to the glucose level control system5802. Although one or more different systems may perform one or moreoperations of the process 6200, to simplify discussions and not to limitthe present disclosure, the process 6200 is described with respect toparticular systems.

The process 6200 begins at block 6202 where the glucose level controlsystem 5802 receives a glucose level of a subject 5804. The block 6202can include one or more of the embodiments previously described withrespect to the block 6102.

At block 6204, the glucose level control system 5802 generates aninsulin dose control signal based at least in part on the glucose levelsignal and a control parameter. The insulin dose control signal may begenerated based on a control algorithm that enables the glucose levelcontrol system 5802 to autonomously determine doses of insulin to beinfused into or administered to the subject to control the blood glucoselevel of the subject. The control algorithm may determine the doses ofinsulin based at least in part on the control parameter. The controlparameter may include any parameter that can affect the operation oroutput of the control algorithm, or the operation of the glucose levelcontrol system 5802, and that is modifiable by a user (e.g., the subject5804 or a user that is at least partially responsible for care of thesubject 5804 (e.g., a parent or guardian)). In some cases, the controlparameter may be, or may correspond to, a target setpoint for theglucose level of the subject 5804. In other cases, the control parametermay correspond to whether the glucose level control system 5802 is togenerate the insulin dose control signal for at least a period of time.For example, the control parameter may relate to whether at least someoperation of the glucose level control system 5802 is paused or active.The block 6204 can include one or more of the embodiments previouslydescribed with respect to the block 6104.

At block 6206, the glucose level control system 5802 tracks one or moreuser modifications to the control parameter over a tracking period. Thetracking period may be one day, less than a day, or it may be longerthan one day (e.g., 2 days, 3 days, a week, a month, etc.). Further, thetracking period may include one or more periods of time as previouslydescribed with respect to the process 6100. The user may be the subject5804 or any other user (e.g., a parent or guardian, or a healthcareprovider) that may be permitted to modify a control parameter of theglucose level control system 5802.

The user may modify the control parameter using a user interface thatmay be generated and/or output by the glucose level control system 5802.Alternatively, or in addition, the user interface may be generatedand/or output by a computing system that can communicate with and/ormodify the control parameter at the glucose level control system 5802.For example, the computing system may be a smartphone, a smartwatch, alaptop, or desktop computer, or any other type of computing device thatmay be used to configure the glucose level control system 5802. The userinterface may be output on a touchscreen with which the user mayinterface to modify the control parameter. The user may interact with acontrol parameter selection element or other user interface element toselect and/or modify the control parameter. In some cases, the user mayprovide the control parameter with any value supported by the glucoselevel control system 5802. In other cases, the user may be limited toselecting particular values for the control parameter, which may be lessthan the supported capability of the glucose level control system 5802or less than what other users are permitted to select. For example, aclinician may be granted a greater modification range than a parent formodifying the control parameter.

Tracking the one or more user modifications may include storing in theone or more user modifications in a therapy log, database, or other datastructure. Further, tracking the one or more user modifications mayinclude tracking or storing whether each of the user modificationscomprises an increase or a decrease in the control parameter. Thedetermination of whether the control parameter has been increased ordecreased may be determined based on whether a value for the controlparameter has been increased or decreased relative to a reference value.The reference value may include a current value of the controlparameter, a default value, a clinical value supplied to the glucoselevel control system 5802, and/or a value determined by the glucoselevel control system 5802. Further, tracking the one or more usermodifications may include storing a time and/or one or more conditionsunder which the control parameter is modified. For example, the glucoselevel control system 5802 may store a time of day, an activity level ofthe subject 5804 as determined from one or more physiological sensorsand/or as identified by a user, a meal being consumed or not consumed,and the like. Moreover, tracking the insulin therapy may include storingan indication of the autonomously determined doses of insulin deliveredor administered to the subject 5804.

In some cases, the tracking period may be divided into a plurality ofsub-periods. The sub-periods may correspond to different portions of aday within the tracking period. For example, each day of the trackingperiod may be divided into two equal halves corresponding roughly to dayand night, or into 3 or 4 different periods corresponding to aparticular number of hours in the day. The sub-periods may be of equalor unequal length. Tracking the one or more user modifications mayinclude tracking the occurrence of modifications to the controlparameter within the sub-periods of the tracking period. Further, theoccurrence of modifications within a sub-period of a day within thetracking period may be combined with the occurrence of modificationswithin a corresponding sub-period of another day within the trackingperiod. In other words, each occurrence of a modification of a controlparameter in a sub-period defined from 9:00-21:00 may be aggregatedacross days of the tracking period.

In some cases, a different reference value may be determined for thecontrol parameter for each sub-period. In some such cases, tracking theone or more user modifications may include tracking modifications to thecontrol parameter value with respect to the reference value for thesub-period.

At block 6208, the glucose level control system 5802 generates a reportof user modifications to the control parameter. Alternatively, or inaddition, the repot may be generated by another computing system, suchas a cloud computing system or a computing system of a healthcareprovider based on data (e.g., occurrences of user modification of thecontrol parameter value) received from the glucose level control system5802.

The report may include a measure of frequency of increases and decreasesfrom the stored control parameter value. Further, the report mayindicate a number of times that operation of one or more features of theglucose level control system 5802 has been paused or suspended, or apercentage of the tracking period that operation of one or more featuresof the glucose level control system 5802 has been paused or suspended.Moreover, the report may indicate a magnitude of the modification toeach control parameter for each occurrence, in total, and/or on average.In some cases, the report may indicate a percentage of usermodifications that are higher or lower than the reference value over thetracking period. Further, cases where the tracking period, or each dayof the tracking period, is divided into a sub-period, the report mayinclude a measure of frequency of increases and decreases from areference value for the control parameter for each sub-period of thetracking period. In some cases, the report may include an identity ofuser activity that occurred when, or within a threshold time period, ofa user modification to a value of the control parameter. For example,the report may identify whether a user was exercising (e.g., swimming,running, dancing, etc.) when a user modification to the controlparameter value was made.

In some embodiments, the block 6208 may include storing the generatedreport at the glucose level control system 5802 (e.g., in the memory5830) and/or at a storage of another computing device. In some cases,the computing device may be a computing device of the subject 5804 (orparent or guardian). Further, the computing device can be a computingdevice of a healthcare provider. In some cases, the computing device maybe a computing device of a cloud computing service.

The report may be obtained from the glucose level control system 5802 bya wired connection (e.g., a USB cable). Alternatively, or in addition,the report may be obtained via a wireless connection to the glucoselevel control system 5802. For example, the glucose level control system5802 may establish an encrypted connection to a computing system of ahealthcare provider, which may receive the report from the glucose levelcontrol system 5802. Alternatively, or in addition, the glucose levelcontrol system 5802 may establish an encrypted communication channelwith a cloud computing provider, which can receive the report from theglucose level control system 5802. This report may then be accessed byany authorized users.

Advantageously, in certain embodiments, a healthcare provider can usethe report to help manage care of the subject 5804. For example, if thehealthcare provider determines that a user is modifying the controlparameter more than a threshold number of times or during particulartime periods, the healthcare provider may use this information to modifythe care being provided to the subject 5804 and/or to educate thesubject 5804 on optimal care. For example, the rate of therapy may needto be modified or the amount of insulin may be too low for the subject'scomfort. For example, in some cases, a subject 5804 may have a differenttolerance to a blood glucose level than the average user leading theuser to modify a setpoint range. Understanding this information can helpthe healthcare provider manage care of the subject 5804 (e.g., adjustingthe initial setpoint range, or modifying a type of insulin prescribed).

Further, as indicated above, the process 6200 may be combined with theprocess 6100. In other words, a report may be generated that includesboth backup therapy protocols and a record of the number of times a usermay a modification to one or more control parameters of the glucoselevel control system 5802. In other cases, the processes 6100 and 6200may be triggered and/or performed independently.

Example Backup Therapy Reports

FIG. 63-FIG. 65 illustrate one non-limiting example of a backup therapyreport, or a set of reports, that may be generated using one or more ofthe embodiments disclosed herein. In other words, the reports of FIG.63-FIG. 65 may be portions of a single report generated by the glucoselevel control system 5802, or may be separate reports that areconcurrently generated or that are generated based on different dataand/or over different tracking periods. The report may be generated bythe automated glucose level control system 5802, or by another computingsystem that may receive therapy data from the automated glucose levelcontrol system. Further, FIG. 63-FIG. 65 represent just one non-limitingexample of a report or set of reports that may be generated. It ispossible for other reports to be generated that include more or lessdata. For example, the backup injection therapy protocol and the backuppump therapy protocol illustrated in FIG. 63 may be separated into twoseparate reports that may be separately generated and/or accessed.

FIG. 63 illustrates a backup therapy protocol report 6300 in accordancewith certain embodiments. The amount of insulin recommended underdifferent ties and/or conditions may be displayed in units. In somecases, the backup therapy protocol report 6300 may identify the quantityof insulin included in a unit and/or the type of insulin. Further, insome cases, the backup therapy protocol report 6300 may be aninteractive report that enables a user to modify a type of insulin or aunit size of insulin. In some such cases, the table 6302 may update therecommended number of units of insulin to administer under particulartimes or conditions based on the type of insulin and or unit size ofinsulin selected.

The backup therapy protocol report 6300 may identify the length of thetracking period 6306 used to determine the backup therapy protocol.Further, the report 6300 may identify the time or date range 6308 duringwhich the tracking period 6306 occurred. Advantageously, knowing thetracking period 6306 may help determine an amount of trust to place inthe recommendations included in the backup therapy protocols. The longerthe tracking period, the more likely that the recommendations areaccurate. A shorter tracking period is more susceptible to less accuraterecommendations because, for example, the tracking period may encompassmore days that are outliers for the subject's typical condition oractivity level. For example, a tracking period of one day that occurs ona day when a subject consumed larger than normal meals or exercisedsignificantly more than normal may result in backup therapyrecommendations that do not match the subject's typical lifestyle.Further, knowing when the tracking period occurred may be useful todetermine how current the recommendations are and whether they are areliable indicator of an amount of insulin a subject should administer.For example, if the date range 6308 of the tracking period 6306 is ayear old, and the subject has gained or lost significant weight over theyear, the backup therapy protocol may no longer be a reliable indicationof recommended injection therapy. In such cases, a user may adjust therecommendation and/or trigger a new occurrence of the backup therapyprotocol generation process 6100.

The table 6302 illustrates an example backup injection therapy protocol,which may indicate various insulin doses that may be administered to thesubject 5804 at various times or under various conditions usinginjection therapy. The table 6302 identifies an amount of insulin thesubject 5804 may inject when consuming a usual-sized meal for breakfast,lunch, or dinner. The usual-sized meal may refer to the size of a mealthat the particular subject 5804 usually consumes or has been advised toconsume by a healthcare provider. The units of insulin specified mayrefer to an amount of insulin that the automated glucose level controlsystem 5802 provides the subject 5804 on average when the user consumesthe identified usual size meal. In some cases, the table 6302 mayfurther include recommended insulin doses for different size meals. Forexample, each breakfast may illustrate three different values (e.g., 5units, 6 units, and 8 units) corresponding to light or smaller thanusual breakfast, usual size breakfast, and heavy or larger than usualsize breakfast.

It should be understood that the amount of insulin delivered may varyover time and/or based on the condition of the patient at a particulartime. Thus, as indicated at the top of the report 6300, therecommendations in the backup therapy protocols are suggested fortemporary use for a particular quantity of time (e.g., up to 72 hours inthe illustrated example). The quantity of time for which therecommendations are valid may vary based on the subject 5804, the amountof historical data collected (e.g., the size of the tracking period),the amount of daily variation in the subject's blood glucose level, orany number of other factors that may affect the amount of time that thebackup therapy protocol can be safely followed.

As illustrated by table 6302, the backup injection therapy protocol mayfurther identify an amount of long-lasting insulin a subject 5804 isrecommended to administer each day (or at certain times throughout theday). This long-lasting insulin may be used in place of the basalinsulin that the glucose level control system 5802 may provide on aperiodic basis.

In addition, the table 6302 identifies the reduction in glucose levelattributable to one unit of insulin. For example, as illustrated in thetable 6302, the automated glucose level control system 5802 hasdetermined that one unit of insulin (e.g., 1/100^(th) of a milliliter ofinsulin) may reduce a subject's 5804 blood glucose level by 9 mg/dL.Accordingly, a user implementing injection therapy may measure asubject's 5804 blood glucose level, determine a difference between themeasured blood glucose level and a desired setpoint or threshold glucoselevel, and divide the difference by 9 to determine a number of units ofinsulin to inject in response to a determination that a correction doseis warranted (e.g., that blood glucose is outside of a desired setpointrange).

The table 6304 of the report 6300 provides an example of a backup pumptherapy protocol. As illustrated, the backup pump therapy protocol mayhave the same therapy information as the backup injection therapyprotocol for mealtimes and for the correction factor. However, because apump may be capable of providing periodic basal therapy, the long actinginsulin units of the injection therapy may be replaced with a basal rateindicating a rate at which the backup or replacement pump shouldadminister insulin to the subject. As illustrated, the basal rate mayvary over time. In the illustrated example, a basal rate is supplied forfour different time periods constituting a 24-hour day. However, thebasal rate may be divided into a fewer (e.g., 2 twelve-hour blocks) orgreater (e.g., every four hours) number of periods, with each timeperiod potentially having a different basal rate as determined based onthe historical therapy data provided by an automated glucose levelcontrol system.

In some cases, the report 6300 may include additional data that may betracked over the tracking period. This additional data may include anydata that may facilitate care of the subject 5804 and/or maintenance ofthe automated glucose level control system 5802. Some non-limitingexamples of additional data that may be tracked and included in a reportusing, for example, the process 6100 or 6200 are illustrated in chart6310 of the report 6300. For example, as illustrated in the chart 6310,the report may include the average blood glucose level of the subject5804 over the tracking period and/or the corresponding estimated A1Cpercentage. Further, the report 6300 may indicate the amount orpercentage of time that the subject's blood glucose level is within adesired setpoint range and/or is above the desired setpoint range.Similarly, the report 6300 may indicate the amount or percentage of timethat the subject's blood glucose level is below a threshold bloodglucose level.

In addition, the report 6300 may indicate the average number of mealannouncements per day. As illustrated in the chart 6310, the subject5804 from which the example report 6300 was generated made an average of4.2 meal announcements indicating that on average, the subject consumedmore than 3 meals a day. In some cases, the report may further indicatethe types of meals announced (e.g., two breakfasts, one lunch, and onedinner). The second breakfast may be a large snack that is roughlyequivalent in size to a small breakfast for the subject. Thus, thesubject may have made an additional breakfast meal announcement. In somecases, the automated glucose level control system 5802 may support aseparate snack or other meal announcement option.

The report 6300 may further include the total amount of insulinadministered to the subject per day, and/or the total amount ofcounter-regulatory agent (e.g., glucagon) administered to the subjectper day. In addition, the report 6300 may indicate the amount ofpercentage of time that the automated glucose level control system 5802is able to connect or communicate with the CGM sensor over the trackingperiod, which may correspond to the amount of time that the automatedglucose level control system 5802 functions in an online mode during thetracking period.

FIG. 64 illustrates a control parameter modification report 6400 inaccordance with certain embodiments. As previously stated, the report6400 may be a separate report generated using, for example, the process6200. Or the report 6400 may be included as a second within the report6300.

The report 6400 may generally provide an indication of the number orpercentage of times that a user modified one or more control parametersof the automated glucose level control system 5802 during a trackingperiod. Further, as with the report 6300, the report 6400 may identifythe time or date range 6308 during which the tracking period 6306occurred. In some cases, a user may interact with the report 6400 todetermine the number of percentage of times that the user modified oneor more control parameters during a subset of the tracking period.Similarly, the user may filter or narrow the date range to view otherdata described herein for a subset (e.g., a selected data range) of thetracking period.

The report 6400 may include a graph 6402 that illustrates the subject'sblood glucose level with respect to the desired target setpoint rangeover the course of a day during the tracking period. This day can be anaverage of the values obtained for each day over the tracking period, orit can illustrate a particular selected day.

Further, the report 6400 may include a table 6404 that indicates thepercentage of times that a user modified the blood glucose target duringspecific time periods. In the table 6402 of the non-limiting examplereport 6400 indicates two time-periods, daytime and nighttime. However,it should be understood that the table 6404 may indicate fewer or moretime periods. Further, the time periods may indicate specific times(e.g., from 9:00 to 21:00 and from 21:00 to 9:00) for the time periods.

As illustrated, the table 6404 may indicate the percentage of times thata user increased or decreased glucose target setpoints. In addition, thereport may indicate the percentage of times that the user did notmodify, or left as usual, the glucose target setpoint. This targetsetpoint indicated in the table 6404 may refer to a single target value(e.g., 108 mg/dL, 125 mg/dL, 130 mg/dL, etc.), or may refer to a targetsetpoint range (e.g., 70-180 mg/dL).

In addition, the report 6400 may indicate the number of times that auser set a temporary glucose target during the tracking period (thetemporary target count 6406) or a selected data range. The report mayalso indicate a number of times that the user paused therapy during thetracking period (e.g., the paused insulin therapy count 6408) and/or theselected date range.

The blood glucose of a subject may be affected by a subject's weight.Accordingly, the subject may provide updates of weight to the automatedglucose level control system. In some such cases, the report mayindicate a change in weight and when the weight parameter was modified(e.g., body weight data 6410). In some cases, the report 6400 may befiltered to show data before and after a weight change separately. Thebody weight data may be helpful for the healthcare provider to, forexample, determine whether weight change may at least in part have beena basis for user modifications to target glucose levels. Generally, theautomated glucose level control system 5802 (e.g., using blood glucosereadings) will automatically account for the effect weight changes mayhave on glucose control. However, the subject 5804 may feel differently.The ability to collect the modification data relating to a user'smodification of the automated glucose level control system 5802 and tocorrelate the data with weight changes can assist a healthcare providerin better treating the subject 5804 by, for example, adjusting settingsof the automated glucose level control system 5802, changing insulinprescriptions, educating the subject 5804, or any other action that mayimprove care of the subject 5804.

In some cases, the report may omit changes to blood glucose targetsettings that are below a threshold. In other words, minor changes thatmay be statistical noise may be ignored. Further, in some cases, thereport may indicate when control parameters (e.g., at bedtime, withrespect to a particular meal, such as dinner, etc.) are modified. Insome cases, the report may also indicate the duration of the change tothe glucose target setpoint, or other control parameter.

FIG. 65 illustrates a meal selection report 6500 that may be included aspart of some implementations of the control parameter modificationreport 6400 of FIG. 64 in accordance with certain embodiments. The mealselection report 6500 may include a table 6502 identifying the averagenumber of times per day that a user (e.g., the subject 5804) announceseach meal type. Typically, a user will announce a meal 0 or 1 times aday. However, in some cases, a user may announce a particular mealtimemore than 1 time to account, for example, for large snacks that may besimilar in size to a particular meal. Smaller snacks often may behandled by the control algorithm of the automated glucose level controlsystem 5802 (e.g., by the corrective insulin controller 5906) without ameal announcement.

Further, the table 6502 may identify the number of times over thetracking period, or selected time period within the tracking period,that meals of particular sizes are announced by a user. For example, thetable 6502 may indicate the number of times that a usual size meal isannounced, a smaller than usual size meal is announce, or a larger thanusual size meal is announced.

Automated Glucose Control Refinement

An ambulatory medical device (AMD) may include a control system thatautonomously provides therapy to a subject, for example, based on ahealth condition of a subject (e.g., determined based on one or moremeasured physiological indicators or parameters of the subject). In someexamples, the control system may determine the therapy time and/or theintensity of the therapy during each therapy delivery based on one ormore measured physiological parameters (e.g., using one or more subjectsensors, such as a CGM sensor) and according to a predictive model thatmay include one or more control parameters. In some examples, thepredictive model may be used to estimate a physiological effect of thetherapy in order to adjust the therapy delivery according to an intendedphysiological effect. It is desirable to adaptively adjust the values ofthe control parameters to optimize the therapy delivery to a subject inthe presence of time varying and subject specific factors that mayinfluence the physiological effects of a therapy delivery on thesubject. In some cases, the AMD may be an ambulatory medicament devicethat regulates the level of an analyte in subject's blood. An example ofsuch ambulatory medicament device is an automated glucose level controlsystem (e.g., the glucose level control system 5802) that mayautomatically provide insulin and/or a counter-regulatory agent (e.g.,Glucagon) to a subject 5804 to help control the blood glucose level(BGL) of the subject 5804. Generally, a control algorithm may beimplemented by the automated blood level glucose level control system5802 to determine when to deliver insulin and/or how much insulin toprovide to the subject 5804. Further, the control algorithm may controlboth an ongoing or periodic delivery of insulin (e.g., a basal dose),and a correction bolus that may be provided to adjust a subject's bloodglucose level to within a desired range. The control algorithm may useblood glucose level readings obtained from a subject sensor (e.g., asensor measuring one or more physiological parameters of the subject inreal time), such as a continuous glucose monitoring (CGM) sensor, thatobtains automated blood glucose measurements from the subject. Moreover,in some cases, the control algorithm may deliver a bolus of insulin inresponse to an indication of a meal to be consumed or being consumed bythe subject 5804.

Insulin may be administered subcutaneously into blood of a subject 5804.For example, the glucose level control system may subcutaneously delivera medicament (e.g., insulin, glucagon) via an infusion set connected toa site on subject's body. There is often a delay, referred to aspharmacokinetic (PK) delay, between when the insulin is provided andwhen the amount of insulin in the subject's blood plasma reaches aparticular concentration level, such as maximum concentration. Thisamount of time may vary based on the type of insulin and/or on thephysiology of the particular subject. For example, with a fast-actinginsulin, it may take approximately 65 minutes for a bolus of insulin toreach maximum concentration in the blood plasma of one subject, but 60,64, or 70 minutes for another subject. For some other types of insulin,it may take anywhere from 3-5 hours to reach maximum concentration inthe blood plasma of the subject. Additionally, there might be a delay,referred to as pharmacodynamic (PD) delay, between variation of theamount of insulin in the subject's blood plasma and the resultingvariation of glucose level in the subject's blood. In some examples, thevalue of pharmacodynamic (PD) delay may be used to estimate BGL based onan estimated concertation of insulin in patient's blood.

In some cases, the glucose level control system may implement apredictive algorithm based on a pharmacokinetic (PK) model to estimatethe accumulation of insulin in the blood plasma of the subject overtime, following the subcutaneous administration of insulin to a subject.In some examples, the PK delay may be subject specific and/or changeovertime. Accordingly, in these examples, the PK model may include oneor more parameters, referred to as control parameters, that may besubject specific and/or change overtime. Examples of factors andparameters that may influence the PK delay and/or the control parametersof the PK model may include, type of insulin, blood glucose level (e.g.,at the insulin administration time), physiological characteristics ofthe subject, health condition of the subject, one or more physiologicalparameters of the subject, time of the administration, location at whichthe infusion set is placed, the amount of insulin administered and thelike. The physiological characteristics may include characteristicsshared among large portions of the population (e.g., weight, gender,age, etc.) as well as characteristics that may be unique or specific tothe subject, or shared among few people (e.g., characteristics relatedto genetics). Differences between the physiologies of different subjectsmay result in differences in the optimal blood glucose range for eachsubject, or some subset of subjects. Further, the differences inphysiologies may also affect the absorption of insulin into the bloodplasma. In other words, different physiologies of different subjects mayresult in insulin absorption taking different amounts of time fordifferent subjects. Thus, while the maximum concentration of glucose inblood plasma may occur 65 minutes after delivery of a bolus offast-acting insulin for one subject, it may be 60 minutes or 70 minutesfor another subject.

Accordingly, in some such examples, the blood glucose level controlsystem 5802 (e.g., the glucose level control system of an AMD) mayimplement a method to adaptively change the one or more controlparameters in of the PK model used in its control algorithm to modifyits predictions, in order to maintain the BGL within a desired range.For example, the glucose level control system may use readings from oneor more subject sensors (e.g., a CGM) and/or information received fromthe subject (e.g., using a user interface of the AMD), to modify one ormore control parameters.

As indicated above, a blood glucose system, such as an automated bloodglucose level control system 5802, may control delivery or administeringof insulin, or a counter-regulatory agent, based on a PK model and oneor more blood glucose level measurements of the subject. In someexamples, the PK model can be a bi-exponential PK model that may be usedto estimate or determine the absorption or accumulation ofsubcutaneously administered insulin into blood and/or a decay rate ofthe insulin level in the subject's blood for a given value of delivereddose of insulin. In some examples, the absorption of insulin over timeaccording to a bi-exponential PK model may be represented by thefollowing equation:

p(t)=KU ₀(e ^(−α) ¹ ^(t) −e ^(−α) ² ^(t))  (2)

where U₀ is the subcutaneous dose in units (U), K is a scaling constant,and α₁ and α₂ are time constants that may be used as the controlparameters of the model. In some examples, the peak time of absorptionof insulin, starting from the time that subcutaneous dose (U₀) isadministered, may be referred to as Tmax and can be determined based onthe following equation:

$\begin{matrix}{\log\frac{\left( \frac{\alpha_{2}}{\alpha_{1}} \right)}{\left( {\alpha_{2} - \alpha_{1}} \right)}} & (3)\end{matrix}$

In some examples, α₁ and α₂ can be related (e.g., through an equationsuch as α₂=1.5 α₁ or any other linear or nonlinear mathematicalrelations). In some such examples, Tmax alone may be used as the controlparameter of the bi-exponential PK model. In some cases, Tmax may bereferred to the time at which the concentration of insulin in subject'sblood reaches a maximum level (e.g., starting from the time thatsubcutaneous dose is administered). In some other examples, thebi-exponential PK model may be used to estimate or determine theaccumulation of counter-regulatory agent or hormone (e.g., glucagon) insubject's blood. Equation 2 may be used to calculate the pending effectof the accumulated amount of insulin in the subcutaneously administereddose, as that can be taken to be the difference between the total area(∫₀ ^(∞)p(t)dt, which can describe a measure of the total amount ofhormone (e.g., insulin) that can be absorbed due to a dose U₀) and ∫₀^(t)p(t)dt, which can represent a measure of the expended portion of U₀at time t.

Often, the glucose level control system is configured to maintain asubject's blood glucose within a particular range (e.g., a normalrange). As blood glucose rises or falls, the glucose level controlsystem may administer particular amounts of insulin orcounter-regulatory agent to the subject to bring the blood glucose levelof the subject back to within a desired range or closer to a desiredsetpoint. As explained above, it may take some non-infinitesimal amountof time for the medicament to be absorbed into the subject's bloodstream. Thus, a PK model (e.g., the bi-exponential PK model), may beused to determine how much insulin or counter-regulatory agent should beprovided to the subject in order to maintain the subject's blood glucosewithin a particular range. In some examples, the PK model (e.g., thebi-exponential PK model) may be used to predict the concentration ofinsulin blood glucose level of the subject over time as insulin orcounter-regulatory agent is administered. In some cases, the controlparameter values of the PK model may be set by a healthcare providerbased on default values obtained through clinical trials and/or based anindividualized treatment plan for the subject as may be determined basedon clinical tests of the subject and/or on the healthcare provider'sevaluation of the subject, which may be determined based on tests of thesubject.

However, as previously indicated, the pharmacokinetic delay and thecontrol parameters of the PK model, may be subject specific and/orchange overtime due to various factors. Thus, although clinical data maydetermine optimal or recommended values of the control parameters for anaverage subject through one or more trials, the determined data may notbe optimal for a particular subject. Moreover, individualized treatmentplans are typically based on point-in-time measurements. Thesepoint-in-time measurements may provide a good guideline for treatment,but the optimal values of the control parameters for a subject may varyat different times of day, due to different activities, due to changesin the subject over his or her lifetime, or for any other number ofreasons.

The glucose level control system 5802 of the present disclosure canimplement a method or process to autonomously and/or automaticallymodify one or more control parameters of a control algorithm, or themodel used by the control algorithm, to modify therapy provided to thesubject using the glucose level control system 5802. The method may beperformed by a hardware separate processor 5820 and/or a controller 5810that controls the administering of therapy. The system can providetherapy (e.g., insulin) to a subject in response to a determination of ablood glucose level of the subject. The blood glucose level may bedetermined based at least in part on a glucose level signal obtainedfrom a glucose level sensor that is operatively connected to a subject.The determination of the therapy (e.g., an amount of insulin orcounter-regulatory agent) may be based at least in part on the bloodglucose level and/or the bi-exponential model. Moreover, thedetermination of therapy may be based at least in part on a value orsetting of one or more control parameters of the glucose level controlsystem. The one or more control parameters may be, or may correspond to,one or more parameters of the bi-exponential PK model, or any othermodel or control algorithm used to control the administering of therapyto the subject.

As mentioned above, the glucose level control system 5802 may providethe therapy based on the value or setting of the one or more controlparameters. The value or setting of the one or more control parametersmay be based on an initial configuration of the glucose level controlsystem 5802 by a healthcare provider, subject, or other user. Further,the initial configuration may be based on clinical data or data obtainedthat is specific to the subject. In some cases, a control parameter maybe a time constant used by a control algorithm of the glucose levelcontrol system (e.g., Tmax in a bi-exponential PK model). This timeconstant may be used in a calculation of an accumulation of insulin inthe subject by the control algorithm. Further, the control parameter maybe used to control an insulin dosing response of the control algorithmto a blood glucose excursion in the subject as indicated by a glucoselevel signal obtained from a glucose level sensor. In some cases, thecontrol parameter may be, or may be related to, Tmax (e.g., defined byequation 2). For example, the control parameter may be an estimate ofTmax or a fraction (e.g., 0.5) of Tmax. As previously explained, Tmaxmay be the peak time of absorption of insulin, or the amount of timeuntil the concentration of insulin from an insulin dose reaches maximumconcentration in the blood of the subject.

Moreover, the control parameter may be associated with a setpoint ortarget blood glucose level, or a blood glucose range. For example, thecontrol parameter could relate to a point in time when an estimatedamount of “insulin on board” (e.g., an amount of insulin in the subjectas determined by a model of insulin accumulation and/or utilization inthe subject) falls below a threshold value. As another example, thecontrol parameter can be a clearance time for insulin boluses (e.g., anestimate of an amount of time for an administered bolus of insulin to beutilized by the subject). In some cases, the control parameter mayrelate to T1/2, which corresponds to a time when the concentration ofinsulin in the blood plasma reaches half of the maximum concentration inthe blood plasma. In some cases, the control parameter may be aparameter that can be used to calculate Tmax or T1/2.

In some examples, the glucose level control system 5802 may determine aneffect of the supplied therapy (herein referred to as therapy effect oreffect). For example, the therapy effect may be determined by analyzinga glycemic control of blood glucose (e.g., variation of BGL or suppliedtherapy over a measurement period) in the subject's blood as indicatedby the glucose level signal received from the glucose sensor (e.g., aCGM sensor). In some cases, the control system may measure or determinethe effect of the supplied therapy over time. In some such cases, thetherapy effect may be determined based on variation of BGL and/or theamount of therapy delivered over time. Moreover, in some cases, thesystem may continue to supply therapy to the subject over severaltherapy delivery times or instances and may average or otherwiseaggregate the measured or determined effects of the therapy over theseveral therapy delivery times or instances. In some other examples, theglucose level control system 5802 may determine the therapy effect basedat least in part on an input received from the subject. The inputreceived from the subject may include a subjective or objective effect.The input received from the subject may include manual blood glucoselevel measurements obtained using, for example, test strips. Anotherexample of input may be an indication of light-headedness, difficultybreathing, headaches, or any other objective or subjective effectidentified by the subject.

Based at least in part on the provided therapy and the measured ordetermined effects of the therapy (e.g., the changes in blood glucoselevel attributed to the therapy), the glucose level control system 5802may autonomously determine a modification to one or more controlparameters. For example, the control system may modify Tmax value usedby the control algorithm (or the PK model used in the controlalgorithm), for example, to improve the effect of a subsequent therapythat may be provided to the subject. As such, the directionalmodification (e.g., increase or decrease) of a control parameter valuemay depend on the measured or determined effect of the therapy providedbased on the initial or prior value of a control parameter. Moreover,the directional modification of the control parameter value may dependon a difference between the determined or measured effect of the bloodglucose therapy and an expected effect of the blood glucose therapy(e.g., calculated based on PK model). In some examples, the directionalmodification of a control parameter may be determined based on theamount of therapy doses provided and/or measured BGL of the subject,during and between one or more previous therapy deliveries.

In some examples, the pharmacodynamic delay for a subject may be a knownvalue. In these examples, the amount of absorbed insulin in thesubject's blood may be estimated based on the measured value of BGLreceived from a glucose sensor. In some such examples, the directionalmodification may depend on the difference between calculated value ofabsorbed insulin based on a PK model (e.g., bi-exponential PK model)with a selected value of Tmax, and the estimated value of the absorbedinsulin based on the measured value of BGL received from a glucosesensor.

Using the modified control parameter, the glucose level control system5802 may determine therapy to deliver to the subject 5804 at a therapydelivery time. As with the initial control parameter, therapy may bedelivered during one or more therapy delivery times based on themodified control parameter. The system may determine the effect of thetherapy delivered based on the modified control parameter using one ormore of the embodiments previously described with respect to the therapydelivered using the initial control parameter.

In some examples, the control system can compare the measured,determined or reported effects (e.g., physiological effects) from thetherapy delivered using the initial value of a control parameter andthose from the therapy delivered using the modified value of the controlparameter. Based on the comparison, the control system may determinewhich values of the control parameter is preferable for the subject. Insome examples, the comparison may be performed in real-time, orsubstantially in real-time. Further, the comparison may be performed bythe glucose level control system 5802 without user interaction. Thecomparison may be performed using a comparison method and based on oneor more comparison criteria.

The comparison method may be based on finite number of therapy effectsdetermined or measured at discrete times or based on continuous temporalvariations of an effect over a period. In some examples the comparisonmethod may involve statistical analysis of the measured or determinedeffects resulting from usage of the initial value and modified value ofthe control parameter. The comparison criterion may be based on theeffects or based on the temporal variations of the effects over aperiod. For example, the preferable control parameter value can be avalue that causes the blood glucose level of the subject to stay withina desired range or closer to a setpoint level for the subject.Accordingly, the system can set or maintain the control parameter tohave the value that generated blood glucose levels that are closer tothe desired range or setpoint for the subject for subsequent therapy.

In some cases, the glucose level control system 5802 may repeat theprocess for different control parameter values enabling the system torefine the glucose control for the subject over time. In subsequentperformances of the process, the initial control parameter value may notbe an initial value but may be the most recent selected value for thecontrol parameter based on the determined effects of the controlparameter.

In some cases, the determination of a second or modified value for acontrol parameter, or the modification of the control parameter may betriggered based on a glucose level of the subject not satisfying athreshold. Alternatively, or in addition, a process of modifying acontrol parameter value may be triggered based on a difference betweenan expected glucose value of a subject and an expected glucose value ofa subject after the administering of therapy exceeding a threshold.

Using the embodiments described herein, the value of a control parametermay be autonomously modified without interaction by a subject or userwith the glucose level control system. In other words, the glucose levelcontrol system can automatically adjust and/or refine a controlparameter used by a control algorithm for glycemic control of thesubject.

As previously described, the glucose level control system may provideboth insulin therapy and counter-regulatory agent therapy to a subject.In some cases, the glucose level control system may only provide insulintherapy. In some such cases, the glucose level control system 5802 mayoutput an indication of an amount of counter-regulatory agent that mayor should be administered to the subject based on a detected conditionof the subject.

The active control parameter value used by the control parameter mayremain active until a subsequent occurrence of the therapy modificationprocess. In some cases, performance of the therapy modification processis continuously performed with the control parameter value beingmodified based at least in part on a determined effect of the priorcontrol parameter value. In other cases, the therapy modificationprocess is performed until the determined effect of the therapysatisfies a desired threshold (e.g., when the detected blood glucoselevel is within a threshold of a setpoint or median setpoint value). Insome cases, the therapy modification process is performed a set amountof times and the control parameter value that provides the best outcome(e.g., closes to desired blood glucose level) is set as the activecontrol parameter for subsequent therapy. In some cases, providingtherapy at different sites on the subject's body (e.g., back, stomach,leg, or arm) may result in different blood glucose absorption rates(associated with different PK delays). Thus, in some such cases, thetherapy modification process may be performed each time the infusion setused to deliver the therapy is moved to a different site on the subject.

Example Automated Glucose Control Refinement Process

FIG. 66 presents a flowchart of an example automated glucose controlrefinement process 6600 in accordance with certain embodiments. Theprocess 6600 may be performed by any system that can autonomously and/orautomatically modify a control algorithm and/or a control parameter thataffects execution of the control algorithm based on feedback (e.g., froma blood glucose signal) relating to therapy administered to a subject5804. For example, the process 6600 may be performed by one or moreelements of the glucose level control system 5802. In some cases, atleast certain operations of the process 6600 may be performed by aseparate computing system that receives blood glucose data from theglucose level control system 5802. Although one or more differentsystems may perform one or more operations of the process 6600, tosimplify discussions and not to limit the present disclosure, theprocess 6600 is described with respect to particular systems.

The process 6600 may be performed automatically and without userinteraction. In some cases, a user may trigger the process 6600 via acommand or interaction with a user interface. However, once the process6600 is triggered, the process 6600 may be performed automatically.Further, the process 6600 may be performed continuously, periodically,or in response to a trigger. The trigger may be time based and/or basedon a measurement of the glucose level of the subject. For example, thetrigger may correspond to a determination that a glucose level of asubject differs by more than a threshold from a predicted glucose levelthat is predicted by a glucose level control algorithm based on theadministering of medicament. Further, the trigger may be based on theactivation or first time use of the glucose level control system 5802 bythe subject 5804.

The process 6600 begins at block 6602 where the glucose level controlsystem 5802 receives a glucose level signal corresponding to the glucoselevel of a subject 5804. The glucose level signal may be received from aglucose sensor capable of measuring the level of glucose in the blood ofthe subject. For example, the sensor may be a continuous glucosemonitoring (CGM) sensor. The block 6602 can include one or more of theembodiments previously described with respect to the block 6102 or 6202.

At block 6604, the glucose level control system 5802 provides a firsttherapy during a first therapy period to the subject 5804. The firsttherapy may be based at least in part on the glucose level signal and afirst value of a control parameter. The control parameter may includeany control parameter that affects operation of the glucose levelcontrol system 5802 and/or performance of a control algorithm of theglucose level control system 5802. The control algorithm may include anycontrol algorithm used to determine a dose of medicament (e.g., insulin)to administer to the subject 5804. In other words, the controller 5810or the separate processor 5820 may use the control algorithm to generatea dose control signal based at least in part on a value (e.g., the firstvalue of the block 6604) of the control parameter to cause the deliverydevice(s) 5806 to administer a dose of insulin or other medicament.

In some cases, the control algorithm may be based on the PK model(equation 2). Further, in some cases, the control parameter may be Tmax,which may be calculated using equation 3. In other cases, the controlparameter may be T_(1/2), which may relate to the amount of time for thedose of insulin in the blood stream to drop to ½ of the maximumconcentration in the blood attributable to the dose administered to thesubject 5804. In some cases, the control parameter corresponds to a timeuntil insulin within blood plasma of the subject reaches a particularconcentration level subsequent to administration of an insulin dose.Moreover, in some cases, the control parameter may be a parameter thataffects the determination of Tmax, such as one or more of the timeconstants α₁ and α₂. In some implementations, the control parameter maybe used by the control algorithm to account for and/or determine anaccumulation of insulin (or other medicament) in the subject 5804 and/ora rate of diminishment of the insulin (or other medicament) in thesubject 5804. In some cases, the control parameter may be used tocontrol an insulin dosing response of the control algorithm to a bloodglucose excursion in the subject as indicated by the glucose levelsignal received at the block 6602.

In some instances, the control parameter may relate to at least one timeconstant used in a calculation of an accumulation of insulin in thesubject by the control algorithm, such as one or more of the timeconstants α₁ and α₂ that may be used in the calculation of Tmax. In somecases, the control parameter may correspond to a rate of insulindiminishment in the subject 5804. In some cases, the control parametermay relate to a target setpoint or a target setpoint range formaintaining or attempting to maintain the subject's 5804 blood glucoselevel.

The first therapy may correspond to a single administering of insulin tothe subject 5804. This single administering of insulin may be any typeof insulin administered for any reason. For example, the insulin dosemay be a basal insulin dose, a priming dose, a dose supplied in responseto a meal announcement, or a correction dose of insulin. Moreover, thefirst therapy may be medicament other than insulin, such ascounter-regulatory agent (e.g., glucagon). In some cases, the firsttherapy may be a plurality of medicament (e.g., insulin and/orcounter-regulatory agent) doses supplied or administered to the subject5804 over the first therapy period. Further, the plurality of medicamentdoses may include a variety of types of medicament doses, such as one ormore basal doses, one or more meal doses associated with one or moremeal announcements, one or more corrective doses, etc.

The first therapy period may be a time period that corresponds to asingle medicament dose. Alternatively, the first therapy period may be atime period that encompasses a plurality of medicament doses. Further,the time first therapy period may be a time period associated with adefined length of time. Alternatively, or in addition, the first therapyperiod may be defined based on a number of medicament delivery periods.In other words, the time period may vary based on the amount of time ittakes to deliver or administer a specified number of doses of medicament(of any type or of a particular type).

The first value may be selected based on a prior therapy or a priorperformance of the process 6600. In some cases, the first value isselected based on a baseline value. The baseline value may be associatedwith clinical data, or it may be determined based on initial operationof the glucose level control system 5802 for some period of time beforeperformance of the process 6600. Alternatively, or in addition, thefirst value may be selected based on clinical data or a particularprescription for the subject 5804. In some cases, the first value may bebased on clinical data for average users or average users that sharecertain physiological data with the subject 5804. In some cases, thefirst value is determined based on a healthcare provider's assessment ofthe subject 5804. Further, the first value may be determined based on aninfusion site (e.g., back, stomach, leg, etc.) for the glucose levelcontrol system 5802. In some cases, the first value may be selectedbased on demographics or characteristics of the subject 5804. Forexample, the first value may be based on the subject's 5804 gender,weight, body mass, or age.

At block 6606, the glucose level control system 5802 determines a firsteffect corresponding, or attributable, at least in part to the firsttherapy. Determining the first effect may include receiving a glucoselevel signal from the glucose level sensor operatively connected to thesubject. This glucose level signal may be a subsequent or updatedglucose reading that is more recent than the glucose level signalreceived at the block 6602. The glucose level signal received at theblock 6602 may be used to determine therapy to administer to the subject5804 and the glucose level signal received at the block 6606 may be usedto determine a result of the administered therapy. It should beunderstood that glucose level signals may be received continuously orperiodically and can be used to both determine therapy to administer andto determine the effect of the administered therapy.

In some cases, determining the first effect may include analyzingglycemic control of blood glucose in the subject as indicated by theglucose level signal. Analyzing the glycemic control of the bloodglucose in the subject may include tracking the blood glucose level ofthe subject 5804 over time. Further, analyzing the glycemic control ofthe blood glucose in the subject may include comparing the blood glucoselevel of the subject 5804 over time to a predicted blood glucose for thesubject 5804 over time as predicted based on the PK model used in thecontrol algorithm using the selected value for the control parameter. Asmentioned above, in some examples, the measured blood glucose level ofthe subject 5804 over time may be used to calculate the accumulationand/or diminishment of the insulin level in subject's blood. In theseexamples, analyzing the glycemic control of the blood glucose in thesubject may include determining whether, or to what degree, thecalculated accumulation and/or diminishment of insulin (or othermedicament) using the PK model (e.g., bi-exponential PK model) and thecontrol parameter values used in the control algorithm matches theaccumulation or diminishment of insulin (or other medicament) estimatedbased on the measured blood glucose level (e.g., obtained from the CGMsensor). In some cases, the first effect may, at least partially, bedetermined by analyzing one or more signals received from one or moresubject sensors that measure one or more physiological parameters of thesubject (e.g., heart rate, temperature and the like).

In yet other examples, the first effect may be determined based on aninput received from the subject (e.g., using a user interface of theAMD). In some cases, the first effect may be determined based at leastin part on an assessment or input provided by the subject 5804 (e.g.,using a user interface) with respect to the first value or the firsteffect. For example, if the subject 5804 feels woozy, dizzy,lightheaded, nauseous, or otherwise uncomfortable during the firsttherapy period, the subject 5804 may, via, for example, a touchscreendisplay of the AMD, indicate how the subject 5804 is feeling.

At block 6608, the glucose level control system 5802 obtains a secondvalue for the control parameter. This second value may be autonomouslydetermined. Further, in some cases, the second value may beautomatically determined. In some cases, the second value is determinedbased at least in part on a user triggering the glucose controlrefinement process 6600. In some such cases the control system maydetermine the second value and present it to the user via a userinterface user interface 5824 of the glucose level control system 5802.

In some other examples, the second value may be obtained from a userinterface 5824 of the glucose level control system 5802 (e.g., inresponse to a user interaction with the user interface). In someexamples, the second value may be obtained from a computing system thatis connected to or otherwise in communication with the glucose levelcontrol system. The communication connection may be a wired or wirelessconnection. Further, the wireless connection may be a direct connection(e.g., via Bluetooth or other near-field communication technologies) ora connection over a network (e.g., a local area network, a wide areanetwork, a cellular network, etc.). The user interface user interface5824 can be implemented in the form of a graphical user-interfaceconfigured to output information and receive information via userinteraction.

The second value may be an increase or decrease of the control parametercompared to the first value. The second value may be limited to aparticular maximum change from the first value. Further, the secondvalue may be selected based at least in part on the first effect. Forexample, if the first effect corresponding to the first value results inblood glucose being near an upper range of the setpoint range, thesecond value may be selected in an attempt to being the blood glucoselevel closer to the middle of the setpoint range. Further, the secondvalue may be selected based at least in part on characteristics of thesubject 5804, such as age, weight, gender, or any other characteristicsthat may affect blood glucose management. In some examples, the secondvalue may be selected based at least in part on the first effectdetermined based on an assessment provided by the subject 5804, in anattempt to reduce the symptoms felt by the subject 5804.

In some cases, the second value of the control parameter may begenerated based at least in part on a baseline value of the controlparameter and an output of a function defined based on glycemic controlof the subject. In some examples, the glycemic control of the subjectmay include the measured value of the glucose level in subject's blood(e.g., provided by the CGM) and/or the amount of therapy (e.g., dose ofinsulin or counter-regulatory hormone) provided during the first therapyperiod. The baseline value of the control parameter may correspond tothe first value used to provide therapy at the block 6604. This baselinevalue may be a last known optimal value for the subject prior to anychanges to the subject (e.g., change in weight, insulin type, ormetabolism changes, etc.). Alternatively, or in addition, the baselinevalue may be a value determined by a healthcare provider. In some cases,the second value of the control parameter is based at least in part onglycemic control indicated by the glucose level signal.

In some cases, the second value may be a modification to Tmax orT_(1/2). It should be understood that Tmax and/or T_(1/2) may, at leastin part, be based on the physiology or biochemistry of the subject 5804.Thus, the setting of either Tmax or T_(1/2) for the setting of the firstvalue and the second value may refer to setting a parameter of thecontrol algorithm or the PK model used by the control algorithm,representative of or corresponding to Tmax and/or T_(1/2). For example,the setting of the first value and the second value may include settingone or more control parameters that may be used to determined orestimate Tmax and/or T_(1/2) for the subject 5804. However, the setvalue may differ from the actual value of Tmax and/or T_(1/2) for thesubject 5804. Further, as Tmax and/or T_(1/2) may vary for differentsubjects, it is not always possible to explicitly set or determine Tmaxand/or T_(1/2) for a subject. Instead, Tmax and/or T_(1/2) may beestimated or determined by comparing the effects and/or blood glucoselevels determined for different control parameter values thatcorrespond, at least in part, to Tmax and/or T_(1/2) Using the process6600, the control parameter may iteratively approach the actual Tmaxand/or T_(1/2) for the subject 5804, or within a threshold of the actualTmax and/or T_(1/2) for the subject 5804. Alternatively, using theprocess 6600, the control parameter (such as one or more of the timeconstants α₁ and α₂) may iteratively approach a value that correspondsto the actual Tmax and/or T_(1/2) for the subject 5804.

At block 6610, the glucose level control system 5802 changes the controlparameter to the second value. Changing the control parameter to thesecond value causes a change in the operation or execution of thecontrol algorithm. This change in the execution of the control algorithmmay result in a change in one or more factors associated with theprovisioning of therapy to the subject 5804. For example, the changingin the execution of the control algorithm may result in a change in anamount of medicament delivered, a timing of the delivery of themedicament, a rate at which a dose of medicament is delivered to thesubject 5804, a target setpoint or target range for the blood glucose ofthe subject, a threshold used in determining whether to delivermedicament (e.g., a threshold difference from the target setpoint), orany other factor that may affect therapy delivered to the subject 5804.

At block 6612, the glucose level control system 5802 provides secondtherapy during a second therapy period to the subject 5804. The secondtherapy is based at least in part on the updated control parameter thatis updated to the second value at the block 6610. As with the firsttherapy, the second therapy may refer to one or a plurality ofmedicament doses. Further, the second therapy period may refer to aspecific amount of time, an amount of time to deliver a particularnumber of medicament doses, or a particular number of medicament doses.In some cases, the block 6612 may include one or more of the embodimentsdescribed with respect to the block 6604 but using the second value forthe control parameter over the second therapy period. In some examples,the duration of the second therapy period may be equal to the durationof the first period. In some other examples, the number of therapiesdelivered during the second therapy period may be equal to the number oftherapies delivered during the first second therapy period.

At block 6614, the glucose level control system 5802 determines a secondeffect corresponding at least in part to the second therapy. The block6614 may include one or more of the embodiments described with respectto the block 6606, but with respect to the second therapy.

At block 6616, the glucose level control system 5802 selects one of thefirst value or the second value based at least in part on a comparisonof the first effect and the second effect. The comparison of the firsteffect and the second effect may be performed autonomously withoutaction by a user. The glucose level control system 5802 may select theone of the first value or the second value to be a current or activevalue for the control parameter based on whether the first effect or thesecond effect results in improved care (e.g., closer to a desiredsetpoint for a greater period of time, or less volatility in bloodglucose values, or any other factor that a healthcare provider may useto evaluate the success of diabetes management) for the subject 5804. Insome cases, the glucose level control system 5802 selects a third valueto the current or active value for the control parameter. The thirdvalue may be selected based on the comparison of the first effect andthe second effect. For example, if it is determined that the firsteffect is preferable to the second effect, the third value may beselected based on a change to the first value in the opposite directionas the change made to the first value to obtain the second value. Forinstance, if in the prior example, where it is determined that the firsteffect is preferable to the second effect, the first value correspondedto a Tmax of 60 minutes, and the second value was selected to correspondto a Tmax of a longer time period (e.g., 65 or 70 minutes), the thirdvalue may be selected to correspond to a Tmax of a shorter time period(e.g., 50 or 55 minutes).

Comparing the first effect and the second effect may include determiningwhether the first value or the second value brought the subject's 5804glucose level closer to a target setpoint and/or maintained thesubject's 5804 glucose level within a target range for a longer periodof time. In some cases, comparing the first effect and the second effectmay include determining whether the first value or the second valueresulted in a more stable blood glucose level for the subject 5804 orless volatility in the blood glucose level of the subject 5804. In somecases, comparing the first effect and the second effect may includedetermining whether the first value or the second value resulted in moreand/or greater excursions of the subject's 5804 blood glucose level froma target blood glucose range.

Comparison of the first effect and the second effect may be performed inreal-time or substantially in real-time accounting for the processingspeed of the hardware separate processor 5820 or the glucose levelcontrol system 5802. Thus, in some cases, the comparison of the firsteffect and the second effect may be performed upon determination of thesecond effect.

In some embodiments, the comparison of the first effect and the secondeffect may include a statistical comparison or statistical analysis ofthe first effect and the second effect. In some cases, the comparison ofthe first and second effects may include determining whether the secondtherapy produced a statistically significant improvement in therapy(e.g., glycemic control) compared to the first therapy. A statisticallysignificant improvement may vary depending on the subject or thecondition of the subject. The comparison can also include adetermination of whether there was a statistically significant increasein risk factors (e.g., hypoglycemia) during the second therapy periodcompared to the first therapy period. In some embodiments, astatistically significant improvement may be an improvement determinedbased on a first statistical analysis of a set of data associated withthe first effect and a second statistical analysis associated with thesecond set of data associated with the second effect. For examples, thefirst and second statistical analysis may include calculating the meanand variance of the blood glucose levels measured during the first andsecond therapy periods, respectively. In some examples, an improvementmay be determined by comparing the mean value and the variance of theblood glucose levels measured during the first and second therapyperiods. In some examples, an improvement may be determined by comparingthe mean value and the variance of the blood glucose levels measuredduring the first and second therapy periods with one or more referencevalues. The reference values may be values provided by a health careprovider or a user and may be stored in the memory 5830 of the glucoselevel control system 5802. In some examples, the first and secondtherapy period may be long enough to include a plurality of therapydeliveries (e.g., infusion of glucose and/or glucagon) during eachperiod. In some embodiments, an improvement may be determined bycomparing by other statistical quantities calculated at least in partbased on the blood glucose levels measured during the first and secondtherapy periods. In some such embodiments the statistical quantities maybe specific statistical quantities defined for comparing the effects ofa therapy (e.g., medicament delivery for controlling the blood glucoselevel in a subject).

In some cases, the first and/or second may be output to user (e.g., thesubject or a parent) via a user interface of the glucose level controlsystem and/or a computing system (e.g., a smartphone, laptop, personalcomputer, or the like). In some examples, the user may use thedetermined effect to adjust the value of a control parameter.

In some cases, the value that better manages the subject's 5804 bloodglucose may be output to a user (e.g., the subject or a parent). Theuser may then configure the glucose level control system 5802 based onthe selected control parameter value. Alternatively, or in addition, theglucose level control system 5802 may automatically modify the value ofthe control parameter. In some cases, the user may be provided with anopportunity to confirm the modification. In other cases, themodification may occur automatically without confirmation. However, themodification may be presented to the user (e.g., the subject or ahealthcare provider) and/or logged in a therapy log.

In some cases, the comparison is performed by another computing systemthat is in communication with the glucose level control system 5802. Forexample, the glucose level control system 5802 may transmit the glucoselevel signal, data determined from the glucose level signal, and/or theassessment received from the subject, indicative of the effect of theglucose control, to another computing system, such as a local computingsystem, a smartphone, or a cloud-based computing system. Further, theglucose level control system 5802 may transmit data associated with thecontrol parameters values and the administering of medicament to thesubject 5804 to the computing system. The computing system may determinethe value of the control parameter that better manages the subject's5804 blood glucose level. The computing system may configure the glucoselevel control system 5802 with the selected value. Alternatively, or inaddition, the selected value may be output to a user who can configurethe glucose level control system 5802 with the selected value.

At block 6618, the glucose level control system 5802 provides therapy tothe subject 5804 based on the selected value for the control parameterthat is selected at the block 6616. The therapy provided at the block6618 may be provided during a third therapy period that is at some pointafter the first and second therapy periods. Thus, during the first twotime periods, the first and second values may be used, respectively, forthe control parameter to determine the value that results in the betteroutcome or improved care for the subject 5804. During subsequent timeperiods, the value that resulted in the better outcome for the subject5804 may be used to provide future care for the subject 5804.Alternatively, a new value that is neither the first or second value maybe used to provide subsequent care in an attempt to find a value for thecontrol parameter that may provide a better or improved level of care(e.g., closer to a desired target glucose level for a longer period oftime) for the subject 5804.

In some examples, providing therapy to the subject, may includegenerating a dose control signal to a delivery device(s) 5806 (e.g.,infusion pump coupled by catheter to a subcutaneous space of the subject5804) that delivers an amount of a medicament (e.g., insulin or acounter-regulatory agent) to the subject wherein the amount may bedetermined by the dose signal.

Providing therapy to the subject 5804 based on the selected value mayinclude configuring the glucose level control system 5802 to providetherapy to the subject 5804 during a third therapy period based at leastin part on the active control parameter value. In some cases,configuring the glucose level control system 5802 to provide therapy tothe subject 5804 based at least in part on the active control parametervalue may end the process 6600. In other cases, the automated glucosecontrol refinement process 6600 may be repeated. Repeating the automatedglucose control refinement process 6600 may include using the selectedvalue (e.g., the first or second value from a prior iteration of theautomated glucose control refinement process 6600) as the first valuewhen performing the operations associated with the block 6604. Thesecond value generated at the block 6608 may be a new value not usedduring the prior iteration of the process 6600.

The process 6600 may be repeated until a difference between the firsteffect and the second effect is less than a threshold difference.Alternatively, or in addition, the process 6600 may be repeated aparticular number of iterations, periodically, in response to a command,or in response to determining that the subject's 5804 blood glucose doesnot satisfy a particular threshold for a particular amount of time.

In some examples, the process 6600 may be used to modify more than onecontrol parameters of a glucose system (or a control algorithm used bythe control system). In some such examples, the process 6600 may be usedto adjust a first control parameter during a first modification periodstarting from block 6602 and ending at block 6618, and to adjust asecond control parameter during a second modification period againstarting from block 6602 and ending at block 6618. The secondmodification period may be immediately after the first modificationperiod or delayed by a particular time. In some example, the controlsystem may determine when a second control parameter should be modifiedfollowing the modification of a first parameter. In some examples, thedelay may be determined at least in part based on the measured glycemiccontrol based on the glucose signal (e.g., received from a CGM sensor).In some other examples, the delay may be determined based on inputreceived from a user. In some examples, the modification of the secondcontrol parameter may be at least partially determined based on thedetermined modification of the first control parameter.

In some examples, a third control parameter may be adjusted during athird time period after adjusting the first and the second controlparameters. The adjustment of the third control parameter mayimmediately follow the adjustment of the second control parameter or mayoccur after a delay. The delay may be determined at least in part basedon the glycemic control of the subject after the second controlparameter is adjusted. In some examples, the glucose level controlsystem may be configured to sequentially adjust the first and second, orthe first, second and third control parameters when the glycemic controlof the subject satisfies one or more threshold conditions. In someexamples, the duration of the time period during which a controlparameter is adjusted may defer from that of the other parameters.

In some embodiments, a modified version of the process 6600 may be usedto determine a value (e.g., an optimal value) of a control parameter. Insome such examples, after determining the second effect at block 6614,the control system may skip block 6616 and block 6618, and insteadobtain a third value for the control parameter. In some examples, thisthird value may be determined at least in part based on the determinedsecond effect at block 6614. In some examples, this third value may beautonomously determined. Further, in some cases, the third value may beautomatically determined. In some cases, the third value is determinedbased at least in part on a user triggering the glucose controlrefinement process 6600. In some such cases the control system maydetermine the third value and present it to the user via a userinterface 5824 of the glucose level control system 5802. In someexamples, the third value may be provided by a user via a user interface5824 of the glucose level control system 5802. In some examples, afterobtaining the third value, the system may provide therapy to the subjectbased on the third value. This modified version of process 6600 may berepeated several times. In some examples, this modified version may berepeated until a difference between the last two subsequent effects isless than a threshold difference. Alternatively, or in addition, themodified version of the process 6600 may be repeated a particular numberof iterations, periodically, in response to a command, or in response todetermining that the subject's 5804 blood glucose does not satisfy aparticular threshold for a particular amount of time.

As described, the process 6600 may be used to modify one or more controlparameters that affect the delivery of insulin. However, the process6600 is not limited as such and may be used to modify one or morecontrol parameters that affect the delivery of other medicaments, suchas counter-regulatory agent (e.g., glucagon, dextrose, etc.). In somecases, the process 6600 may be used to recommend a change in insulinand/or counter-regulatory agent delivery without modifying the delivery.This can be advantageous for generating recommendations regardingcounter-regulatory agent in a single hormone glucose level controlsystem 5802 that does not support counter-regulatory agent, or thatsupports the use of counter-regulatory agent, but does not have thecounter-regulatory agent available.

Moreover, in cases where the process 6600 is used to modify multiplecontrol parameters, the at least two or more of the control parametersmay be related to each other. For example, if the control parametersinclude the time constants α₁ and α₂, there may be a relationshipbetween α₁ and α₂ such that modifying al may cause a modification to α₂.For instance, α₂ may equal 1.5 times α₁

The value for the control parameter set as the active parameter (e.g.,the first value or the second value) at the block 6616 may be used bythe control algorithm to provide therapy to the subject 5804 for aparticular period of time or until the process 6600 is repeated. Aspreviously explained, in some cases, the process 6600 is repeatedperiodically and/or in response to a trigger, such as a blood glucosevalue or an average blood glucose value over a time period, or anindicate of a site change for the connection of the glucose levelcontrol system 5802 to the subject 5804 (e.g., a change in the locationof the infusion set used to provide the subcutaneous dose).

Hypothetical Example

As previously described, the peak time of absorption of insulin may bereferred to as Tmax. Different types of insulin may result in differentamounts of time until peak absorption into the subject's blood or fordifferent subjects. For example, in one hypothetical example, theaggregate Tmax among subjects for the fast-acting insulin lispro andinsulin aspart may be determined to be approximately 65 minutes, whilethe aggregate Tmax among subjects using ultra-fast-acting insulin, suchas, for example, the insulin aspart injection marketed under the Fiaspbrand, which has a formulation to decrease time to peak absorption, maybe determined to be approximately 40 minutes. When using an automatedblood glucose level control system (such as the glucose level controlsystem 5802) with a control parameter corresponding to Tmax set to 65minutes, there may be no statistically significant improvement in theaverage glucose level or the frequency of hypoglycemia when using theultra-fast-acting insulin compared to using the fast-acting insulin. Inthis comparison, Tmax is held constant while varying the type of insulinused.

When adjusting the value of the control parameter for the automatedblood glucose level control system to use different Tmax settings, in ahypothetical example, mean glucose drops when Tmax is lowered when usingthe ultra-fast acting insulin. In this example, three cohorts ofsubjects employ control algorithms that use modified Tmax values whenusing a glucose level control system with ultra-fast-acting insulin suchas Fiasp. The first cohort uses a blood glucose level control systemconfigured with a Tmax of 65 minutes for a first week of therapy and alower Tmax (such as, for example, 50 minutes) for a subsequent week oftherapy. The second cohort uses the blood glucose level control systemconfigured with a Tmax of 65 minutes for the first week of therapy andan even lower Tmax (such as, for example, 40 minutes) for a subsequentweek of therapy. The third cohort uses the blood glucose level controlsystem configured with a Tmax of 65 minutes for the first week oftherapy and a sharply lower Tmax (such as, for example, 30 minutes) fora subsequent week of therapy. Comparison of the change in Tmax withineach cohort and across cohorts demonstrates that the mean glucose leveldrops when Tmax is lowered, and there is no statistically significantincrease or decrease in hypoglycemia.

When Tmax is shorter than physiological insulin absorption peak time,there is an increased risk of hypoglycemia because the blood glucoselevel control system may stack or administer multiple doses of insulinwithin a time period. This may occur because the blood glucose levelcontrol system may incorrectly identify a lower blood glucoseconcentration as a maximum blood glucose level concentration when Tmaxis set below the actual peak insulin absorption time.

By using the process 6600 to compare the effect of different Tmaxsettings, it is possible to optimize the Tmax setting for a subjectand/or a particular type of insulin. In some examples the comparison maybe based on one or more statistical methods. For example, using theglucose concentration data collected during a therapy period (e.g.,using a CGM sensor), the control system may determine whether there is astatistically significant difference in mean glucose level during alater period using a different Tmax value compared to an earlierevaluation period. If the subsequent or newer value used for Tmaxresults in an improved effect, Tmax or a control parameter of the bloodglucose level control system 5802 corresponding to Tmax may be set tothe newer value, where the change in the control parameter value mayoccur automatically upon determination of a statistically significantimprovement or may occur after generating a notification of thepotential improvement and receiving confirmation that the change incontrol parameter value should occur. After collecting glucose signalsof the subject 5804 for a period of time at a default or prior value forTmax, the value for Tmax may be lowered by a significant amount from theinitial Tmax. For example, the control algorithm may automaticallychange Tmax or an associated time constant to reflect a Tmax reductionof at least 10 minutes, at least 5 minutes, at least 2 minutes, no morethan 15 minutes, no more than 20 minutes, no more than 30 minutes, or bya change within a range spanning between any two of the preceding valuesin this sentence, where the preceding values are included in the range.The system can perform a statistical analysis between the prior data setassociated with the higher Tmax, and the current data set associatedwith the lower Tmax. If the controller of the blood glucose levelcontrol system determines that there is a significant or statisticallysignificant improvement (e.g., more than a threshold improvement) in themean glucose level for the subject with little or no increase inhypoglycemia events or risk events, the system can adopt or recommendthe lower Tmax value as the preferred Tmax. This process can be repeatedusing additional reductions in Tmax. In some cases, each reduction inTmax may be smaller than the previous reduction. Moreover, if it isdetermined that there is a not an improvement in the mean glucose levelfor the subject and/or if there is an increase in hypoglycemia orhypoglycemia risk events, the system may use the prior Tmax or mayselect a Tmax between the new Tmax and the prior Tmax. Thus, using theprocess 6600, the system can iteratively modify Tmax to find an optimalvalue for the subject and/or the selected insulin type.

Moreover, by performing real-time analysis and optimization of one ormore control parameters, maintenance of the subject's diabetes can beimproved faster and more accurately compared to delayed analysis thatmay occur during clinical testing. Clinical testing may be less accurateas physiological changes in the subject may not be captured in realtime.

In some cases, the real-time process and statistical analysis describedabove can be used to analyze other types of biomedical data obtained byone or more subject sensors (e.g., measuring one or more physiologicalparameters). In some such cases, the additional biomedical data, such asdata may be received from a smartwatch (e.g., blood pressure, heartrate), from a weight sensor, or any other type of biomedical sensor. Byadapting the process 6600 to perform statistical analysis of theadditional biomedical data, it is possible to perform a quantitativelyobjective analysis of biometric data, which can be used by a healthcareprovider to care for a subject.

Further, the outcomes of the comparative analysis described above may beused to make additional recommendations to the subject. For example, ifit is determined that the actual Tmax for a particular type of insulinis higher than expected for the subject, it may be recommended that thesubject modify his or her diet in a particular manner while using thatparticular type of insulin.

Example Simulations

Embodiments of an automated glucose level control system 5802 that canbe adapted for use with embodiments of the present disclosure aredescribed in International Publication No. WO 2015/116524, published onAug. 6, 2015; U.S. Pat. No. 9,833,570, issued on Dec. 5, 2017; and U.S.Pat. No. 7,806,854, issued on Oct. 5, 2010, the disclosures of each ofwhich are hereby incorporated by reference in their entirety for allpurposes.

The automated glucose level control system 5802 can autonomouslyadminister insulin doses and account for online accumulation of insulindoses (“insulin on board”) due to the finite rate of utilization of theinsulin. The rate the insulin absorption, and in turn accumulation, ofinsulin doses may be modeled by a pharmacokinetic (PK) model (e.g., thebi-exponential PK model represented by equation 2 with preset values oftime constants α1 and α2). Of significant clinical significance inrelation to the PK model is the time it takes for an insulin dose (e.g.,administered subcutaneously) to be absorbed in subject's blood. In someexamples, the peak time for insulin absorption in blood is referred toas Tmax. In some other examples. In some other examples, Tmax may be thetime at which the concentration of insulin reaches its maximum valuefollowing the delivery of a specific dose of insulin. In some suchexamples, Tmax may be measured from the time that insulin is provided tothe subject (e.g., subcutaneously using an infusion set).

In some examples, setting the time constants in the PK model (e.g., α₁and α₂ in equation 2) may be equivalent to setting Tmax that isinherently assumed by the model; conversely, setting Tmax may set thetime constants of the PK model. Since the values of the time constantsmay be used to determine the online calculation of the accumulation ofinsulin by a control system, the value of the time constants mayconsequently control the control system's insulin dosing response to agiven blood glucose level excursion. Thus, varying Tmax or timeconstants associated with Tmax controls the aggressiveness of thecontrol system's insulin doses.

In certain embodiments, the control system implements a method to adaptthe control system's PK model's Tmax (hence time constants) settingonline. This method may be performed either by the control systemperiodically making online assessments and calculations that producerecommendations of modifications in Tmax or by the control systemautonomously modulating Tmax online. In either case, the calculationsmay be based on the control system's performance over some time period.In some cases, adaptations to Tmax online, whether autonomouslyoccurring or issued as recommendations can be based on theglucose-control performance by the control system over some timeinterval, including trends in glucose level, mean glucose level, orextent and/or duration of low glucose level (hypoglycemia) and/or highglucose level (hyperglycemia) occurrence. Alternatively, the calculationcan be based on the usage of a counter-regulatory agent, the otherwiseintended usage of a counter-regulatory agent had it been available(e.g., in insulin-only systems or in cases where the counter-regulatoryagent or its delivery channel are temporarily unavailable). The methodcan impose upper and/or lower (static or dynamic) bounds for the rangeover which the Tmax can vary. The degree of adaptation in Tmax for agiven situation can be different depending, for example, on the specificinsulin being administered by the control system.

In certain embodiments, the described method may be applicableregardless of whether the continuous glucose monitor (which can providethe input glucose signal to the control system) is online or offline.For example, the method disclosed herein can be applied to systemdescribed in International Publication No. WO 2015/116524. Further, thedescribed method can coexist with other aspects of the system beingactivated or not, such as, but not limited to, having a glucose targetthat is adapted automatically by the system, e.g., as in the systemdescribed in International Publication No. WO 2017/027459, published onFeb. 16, 2017, which is hereby incorporated by reference herein for allpurposes.

As previously described, the absorption of subcutaneously administeredinsulin into blood may be governed by the bi-exponential PK model ofequation 2. Setting the time constants in the PK model may set a measureof the pending effect of the accumulated amount of insulin in thesubcutaneously administered dose, as that can be taken to be thedifference between the total area (∫₀ ^(∞)p(t)dt, which can describe ameasure of the total action over time due to a dose U0) and ∫₀^(t)p(t)dt, which can represent a measure of the expended portion of U0.The peak time, Tmax, of the absorption of insulin doses into blood maybe given by equation 3. Thus, setting Tmax may set the PK model timeconstants, which can directly govern the magnitude (e.g., aggressive orconservative) of the control system's online insulin dosing response toa given glucose profile. Although not limited as such, for simplicity,assume that α₁ and α₂ are related, e.g. α₂=1.5 α₁.

The bi-exponential PK model may be used to simulate the relation betweena glucose profile and the medicament (e.g., insulin or glucagon) dosesdelivered to a subject. FIG. 67A-FIG. 67C illustrate a simulationdemonstrating an effect that increasing or decreasing the Tmax setting,or value for a control parameter corresponding to Tmax, may have on theglucose level control system's glucose level control system 5802 onlineinsulin and glucagon dosing response to a given glucose profile (e.g.,temporal variation of blood glucose level over 24 hours).

FIG. 67A illustrates a simulation of glucose control of a subject withTmax set to 65 minutes. The graph 6702 illustrates the variation ofblood glucose level (BGL) of a subject over 24 hours. The range 6704indicates the desired target setpoint range (e.g., between 70 and 120mg/dL) for the subject's blood glucose level. Further, the range 6706indicates the range in glucose level (e.g., below 60 mg/dL) for thesubject that is associated with hypoglycemia or a risk of hypoglycemia.The graph 6708 a illustrates the administering of medicament (insulin orglucagon) to the subject over the same 24-hour time period as graph 6702based at least in part on the blood glucose level variation illustratedin the graph 6702.

FIG. 67B illustrates a simulation of glucose control of a subject withTmax set to 15 minutes. The graph 6708 b corresponds to the graph 6708a, but with Tmax set to 15 minutes instead of 65 minutes. As illustratedby comparing the graph 6708 b to 6708 a, reducing Tmax to 15 minutes mayresult in an increase in insulin dosing required to maintain the givenglucose profile 1400.

FIG. 67C illustrates a simulation of glucose control of a subject withTmax set to 130 minutes. The graph and 6708 c corresponds to the graph6708 a, but with Tmax set to 130 minutes instead of 65 minutes. Asillustrated by comparing the graph 6708 c to 6708 a, increasing Tmax to130 minutes may result in a decrease in insulin dosing required tomaintain the given glucose profile 1400.

Even if the glucose profile of a subject is unchanged, increasing ordecreasing insulin (or counter-regulatory agent) dosing may affect careof the subject 5804. For example, the subject may experience differentdegrees of symptoms (e.g., dizziness, nausea, etc.) attributable tomaintenance of the subject's diabetes. Advantageously, autonomousoptimization of one or more control parameters of a glucose levelcontrol system, may reduce the amount and/or frequency of the medicamentdoses required to maintain a normal glucose profile.

The simulations illustrated in FIG. 67A—FIG. 67C illustrate onenon-limiting example of the impact of modifying a control parameter of aglucose level control system. In some cases, different dosing maysubsequently lead to different blood glucose excursions which in turnmay vary the determined insulin-glucagon doses subsequently.Nonetheless, the simulations shown in FIG. 67A—FIG. 67C, demonstrate thecorrelation between Tmax as a control parameter and the determinedmedicament doses by the glucose level control system 5802 for eachtherapy. Further these simulations demonstrate that the determinedtherapy doses may be used as a feedback to adjust Tmax as descriedbelow.

Example Automated Glucose Control Refinement Process

In some implementations, the value of Tmax can be varied automaticallyonline based on glycemic control in a receding time period. For example,Tmax can be described using the following the equation:

T _(max)(k)=T _(max) ^(o)+ƒ(y _(k) ,g _(k)),  (4)

where T_(max) ^(o) is a baseline value of Tmax, ƒ(y_(k), g_(k)) is aparameter control adjustment function (herein referred to as adjustmentfunction), based on glycemic control of the glucose signal, y_(k),and/or the amount of counter-regulatory dosing, g_(k), that is computedby the control system (whether delivered or not). Evaluation of ƒ(y_(k),g_(k)) could be over a time period (e.g., one week, two weeks, fourweeks or other time intervals). For example, ƒ(y_(k), g_(k))=Σ_(k-N)^(k) ƒ(y_(n), g_(n)). In some examples, k may represent a currenttherapy period and N may indicate a receding time period that mayinclude one or more therapy periods.

The parameter control adjustment function ƒ(y_(k), g_(k)) can cause anincrease in T_(max)(k) relative to T_(max) ^(o) for an increase inhypoglycemia (in severity and/or duration) or impending hypoglycemia inglycemic control of the glucose signal, y_(k), over the receding timeperiod (that may include one or more therapy periods) and, conversely,can cause a decrease in T_(max)(k) relative to T_(max) ^(o) for anincrease in hyperglycemia (in severity and/or duration) in glycemiccontrol of the glucose signal, y_(k), over the receding time period.Moreover, ƒ(y_(k), g_(k)) can cause an increase or decrease T_(max)(k)in relative to T_(max) ^(o) respectively for an increase or decrease inamount of counter-regulatory dosing, g_(k), over the receding timeperiod. The adjustment ƒ(y_(k), g_(k)) to T_(max)(k) can be evaluatedand effected at discrete times, which can be at scheduled periodicintervals (e.g., once every 24 hours, once every three days, once aweek, etc.), in response to a user command, or based on a physiologicalmeasurement of the subject. Alternatively, or in addition, adjustmentscan be evaluated and effected online when some metric satisfies athreshold or meets certain criteria within the current computationwindow (e.g., a week, a month, etc.). This criterion can include whenhypoglycemia in y_(k) reaches or crosses a certain threshold or thelevel of counter-regulatory dosing in g_(k) reaches or crosses a certainthreshold. Alternatively, or in addition, the adjustment can be effectedafter some evaluation related to the glucose signal y_(k) (e.g., meanvalue) in the current computation window has attained a statisticallysignificant difference from its evaluation in a preceding computationwindow (e.g., the week before). These described implementations allowfor having dynamic instances that are mathematically determined onlineas to when T_(max)(k) gets adjusted and/or the magnitude by which it isadjusted.

In some examples, therapy periods can be scheduled regular or periodictime intervals (e.g., 24 hour periods, two day periods, one weekperiods, etc.), based on a user command, or based on a physiologicalmeasurement of the subject. In some other examples, therapy periods maybe defined as the time interval between two subsequent therapydeliveries, and each therapy period may be identified based on thetherapy delivery time that marks the beginning of the therapy period. Ineither case, ƒ(y_(k), g_(k)) may be the adjustment to T_(max) for thek^(th) therapy period and ƒ(y_(k), g_(k)) may be evaluated based on theequation ƒ(y_(k), g_(k))=Σ_(k-N) ^(k) ƒ(y_(n), g_(n)) wherein y_(n) isthe glucose signal measured during the n^(th) therapy period, g_(n) isthe computed dose of a counter-regulatory hormone for the n^(th) therapyperiod and N indicates the receding time period that may include one ormore therapy periods. In some examples, N may be the number of thetherapy periods receding the k^(th) therapy period.

FIG. 68 illustrates a graph 6800 of an example of blood glucose levelsignal G(t) 6802 (e.g., a CGM trace received from a CGM sensor) over atherapy period (starting from t_(S) 6804 and ending at t_(E) 6806)during which one or several doses of insulin and/or a counter-regulatoryagent (e.g., glucagon) are determined and/or administered by the glucoselevel control system 5802. For example, an insulin dose of U_(i) 6808units may be provided at time t_(u,i) 6810 at a measured glucose levelof G_(u,i) 6812 (where i varies from 1 to the number of insulindeliveries between t_(S) 6804 and at t_(E) 6806). Similarly, the controlsystem may have calculated a dose of C_(j) 6814 units, that may havebeen administered or not, a glucose level G_(c,j) 6818 at which glucagonmay have been delivered and the time t_(c,j) 6816, at which glucagon mayhave been delivered, (where j varies from 1 to the number of glucagondeliveries between t_(S) 6804 and at t_(E) 6806). The control system maybe configured to provide therapy in order to maintain the BGL within anormal range defined by an upper bound G_(max) 6820 and a lower boundG_(min) 6822 and close to a G_(set) 6824. In some examples, the glucoselevels above upper bound G_(max) 6820 may indicate hyperglycemia andglucose levels below lower bound G_(min) 6822 may be consideredhypoglycemia. For example, during the therapy period shown in FIG. 68,two instances of hyperglycemia 6826 and two instances of hypoglycemia6828 may be identified by the control system. In some examples, duringeach therapy period the control system may store blood glucose levelsignal G(t) 6802, t_(u,i) 6810, t_(c,j) 6816, U_(i) 6808 and C_(j) 6814,for all therapy deliveries (all values of i and j). In some examples,the value of one or more control parameters (e.g., Tmax, G_(set)) maynot change during the therapy period between t_(S) 6804 and t_(E) 6806.

FIG. 69 presents a flowchart of an example automated blood glucoserefinement process 6900 that may use the above-mentioned modificationmethod to control Tmax and/or other control parameters of a glucoselevel control system. The process 6900 may be performed by any systemthat can autonomously and/or automatically modify a control algorithmand/or a control parameter that affects execution of the controlalgorithm based on feedback (e.g., from a blood glucose signal) relatingto therapy administered to a subject 5804. For example, the process 6900may be performed by one or more elements of the glucose level controlsystem 5802. In some cases, at least certain operations of the process6900 may be performed by a separate computing system that receives bloodglucose data from the glucose level control system 5802. Although one ormore different systems may perform one or more operations of the process6900, to simplify discussion and not to limit the present disclosure,the process 6900 is described with respect to particular systems.

The process 6900 may be performed automatically and without userinteraction. In some cases, a user may trigger the process 6900 via acommand or interaction with a user interface. However, once the process6900 is triggered, the process 6900 may be performed automatically.Further, the process 6900 may be performed continuously, periodically,or in response to a trigger. The trigger may be time based and/or basedon a measurement of the glucose level of the subject. For example, thetrigger may correspond to a determination that a glucose level of asubject differs by more than a threshold from a predicted glucose levelthat is predicted by a glucose level control algorithm based on theadministering of medicament. Further, the trigger may be based on theactivation or first time use of the glucose level control system 5802 bythe subject 5804.

The process 6900 begins at block 6902 where a first value is selectedfor a control parameter (e.g., a control parameter that may beadaptively modified) of the glucose level control system 5802. Forexample, the control parameter can be a Tmax value used in the controlalgorithm of the glucose level control system 5802. In some examples,Tmax may be related to one or more parameters in a PK model used by thecontrol algorithm. As another example, the control parameter can be asetpoint (e.g., G_(set) 6824 in FIG. 68) or the target value for themeasured value of the blood glucose concentration of a subject 5804(e.g., measured using a CGM sensor).

The first value of the control parameter may be selected based on abaseline value. The baseline value may be associated with clinical data,may be determined based on operation of the glucose level control system5802 for some period of time before performance of the process 6900, ormay be determined from a prior performance of the process 6900.Alternatively, or in addition, the baseline value may be selected basedon clinical data or a particular prescription for the subject 5804. Insome cases, the baseline value may be based on clinical data for averageusers or average users that share certain physiological data with thesubject 5804. In some cases, the baseline value is determined based on ahealthcare provider's assessment of the subject 5804. Further, thebaseline value may be determined based on an infusion site (e.g., back,stomach, leg, etc.) for the glucose level control system 5802. In somecases, the baseline value may be selected based on demographics orcharacteristics of the subject 5804.

At block 6904, the glucose level control system 5802 provides therapyover a time period to the subject 5804. based at least in part on thefirst value of the control parameter. Further, the therapy may beprovided based at least in part on one or more glucose signals receivedduring the time period. The glucose signals may be received from aglucose sensor (e.g., a CGM) and may correspond to a glucose level ofthe subject. In some cases, the time period may include one or moretherapy periods. In some examples, the number of therapy periodsincluded in the time period may be equal or unequal therapy periods. Atherapy period may be a time period that corresponds to a singledelivered medicament dose, which may include an instantaneous deliveryor a delivery of the medicament dose over a period of time.Alternatively, a therapy period may be a time period that encompasses aplurality of medicament dose deliveries. Further, a therapy period maybe a time period associated with a defined length of time.Alternatively, or in addition, the therapy period may be defined basedon a number of medicament periods. In other words, the time period mayvary based on the amount of time it takes to deliver or administer aspecified number of doses of medicament (of any type or of a particulartype).

In some examples, the time of delivery and dose of the plurality oftherapies may be based at least in part on the glucose level signal andthe first value of a control parameter of the control algorithm used bythe glucose level control system 5802. The control parameter may includeany control parameter that affects operation of the glucose levelcontrol system 5802 and/or performance of a control algorithm of theglucose level control system 5802.

For example, the control parameter can be Tmax, T_(1/2), speed ofdelivery of a medicament dose, a setpoint for the glucose level, a bloodglucose range, a threshold value of blood glucose level (e.g., a maximumor minimum value) and the like. The control algorithm may include anycontrol algorithm and/or PK model used to determine a dose of medicament(e.g., insulin) to administer to the subject 5804. In other words, thecontroller 5810 or the processor 5820 may use the control algorithm togenerate a dose control signal based at least in part on a value (e.g.,the first value selected at the block 6902) of the control parameter tocause the delivery device(s) 5806 to administer a dose of insulin orother medicament.

Each therapy of the plurality of the therapies provided over the timeperiod, may correspond to a single administering of insulin to thesubject 5804. This single administering of insulin may be any type ofinsulin that may be administered for any reason. For example, theinsulin dose may be a basal insulin dose, a priming dose, a dosesupplied in response to a meal announcement, or a correction dose ofinsulin. Moreover, each therapy provided may be a medicament other thaninsulin, such as counter-regulatory agent (e.g., glucagon). In somecases, each therapy delivery may include a plurality of medicament(e.g., insulin and/or counter-regulatory agent) doses supplied oradministered to the subject 5804 over a therapy period. Further, theplurality of medicament doses may include different types of medicamentdoses, such as one or more basal doses, one or more meal dosesassociated with one or more meal announcements, one or more correctivedoses, etc.

In some examples, the value of the control parameter that is beingadjusted may change from one therapy period to another therapy periodduring the time window. For example, the value of the control parametermay change by a given amount in the beginning of each therapy period orgroup of therapy periods. In some other examples, the value of thecontrol parameter may change by a given amount after certain number oftherapies. In some examples, the amount by which the control parameteris changed may be determined based on one or more receding therapyperiods in the time window. In some cases, the block 6904 may includeone or more of the embodiments described with respect to the process6600.

In some examples, during the therapy period or one or more therapyperiods of the plurality of therapy periods included in the time period,therapy data may be obtained and/or stored. With reference to FIG. 68,in some examples, therapy data may include the glucose signal bloodglucose level signal G(t) 6802, the calculated or actual delivery time(t_(c,j) 6816) and the estimated or delivered amount of acounter-regulatory agent (C_(j) 6814). This therapy data may be storedin the memory 5830 of the glucose level control system 5802. Further,the therapy data may include a total amount of the counter-regulatoryhormone administered during a therapy period. Alternatively, or inaddition, other parameters and data associated with each therapy periodmay be stored in the memory 5830. For example, the total amount ofinsulin administered, an amounts of insulin delivered (U_(i) 6808), adelivery time (t_(u,i) 6810) of the insulin delivered during eachtherapy period, data received from other sensors that may measure one ormore physiological parameters of the subject, data received from thesubject or user (e.g., via a user interface), and the like.

At block 6906, the glucose level control system 5802 determines acontrol parameter adjustment for the control parameter. The controlparameter adjustment may be based at least partially on the therapydata. In some embodiments, the adjustment may be determined using anadjustment function. For example, the adjustment function may be thefunction ƒ(y_(k), g_(k)) for modifying Tmax according to equation 4. Insome examples, the control parameter adjustment may be determined byanalyzing glycemic control of blood glucose in the subject as indicatedby the glucose level signal (e.g., G(t) 6802 or the CGM trace).Analyzing the glycemic control of the blood glucose in the subject mayinclude tracking the blood glucose level of the subject 5804 over time.Further, analyzing the glycemic control of the blood glucose in thesubject may include comparing the blood glucose level of the subject5804 over time to a predicted blood glucose for the subject 5804 overtime estimated based on the PK model and control parameter values usedin the control algorithm. In some examples, the value of the adjustmentfunction ƒ(y_(k), g_(k)) may be calculated at least in part using theestimated or actual values of t_(c,j) 6816, C_(j) 6814, and glucoselevel G_(c,j) 6818, (where j varies from 1 to the number ofcounter-regulatory provided during the time period). In some otherexamples, determination of the adjustment function ƒ(y_(k), g_(k)) mayinclude a statistical analysis based on the estimated or actual valuesof t_(c,j) 6816, C_(j) 6814, and glucose level G_(c,j) 6818, (where jvaries from 1 to the number of counter-regulatory provided during thetime period). In some such examples, the statistical analysis may bebased on statistical quantities and/or the analytical tools describedbelow.

In some cases, the adjustment to the control parameter may be determinedbased on the number of hypoglycemia 6828 and/or hyperglycemia 6826events and/or duration of each event. In some examples, the adjustmentto the control parameter may be determined based on the differencebetween measured glucose level and the setpoint (G_(set) 6824). In someexamples, the adjustment may be determined based on the time intervalsduring which the glucose level stays within a target range (e.g.,between upper bound G_(max) 6820 and lower bound G_(min) 6822). In somecases, the adjustment may be determined based on the stability of themeasured blood glucose level for the subject 5804 or less volatility inthe blood glucose level of the subject 5804. For example, a statisticalanalysis may be performed to determine the distribution rate of changefor G(t) beyond one or more threshold rates.

In some cases, the adjustment to the control parameter may, at leastpartially, be determined by analyzing one or more signals received fromone or more subject sensors that measure one or more physiologicalparameters of the subject (e.g., heart rate, temperature and the like).In yet other examples, the adjustment to the control parameter may bedetermined based on an assessment or input received from the subject5804 (e.g., using a user interface of the AMD). For example, if thesubject 5804 feels woozy, dizzy, lightheaded, nauseous, or otherwiseuncomfortable during one or a plurality of therapy periods, the subject5804 may, via, for example, a touchscreen user interface or otherinterface of the AMD, indicate how the subject 5804 is feeling.

The adjustment may be determined in real-time or substantially inreal-time accounting for the processing speed of the hardware separateprocessor 5820, the glucose level control system 5802, or the time forthe subject to provide an assessment of his or her condition to theglucose level control system 5802. In some cases, the adjustment to thecontrol parameter may be determined by a computing system that is incommunication with the glucose level control system 5802. For example,the glucose level control system 5802 may transmit the therapy data, toanother computing system, such as a local computing system, asmartphone, or a cloud-based computing system. Further, the glucoselevel control system 5802 may transmit the therapy data and dataassociated with the control parameters values to the computing system.The computing system may determine the adjustment that better managesthe subject's 5804 blood glucose level in the next time period.

At block 6908, the glucose level control system 5802 adjusts the controlparameter using the control parameter adjustment determined at the block6906. In some examples, the adjustment may be performed autonomously orautomatically. In some other examples, the control parameter adjustmentdetermined at block 6906 may be presented to the subject or other user(e.g., parent, guardian, clinician, etc.) via a user interface (e.g., atouchscreen display). In some such cases, the subject or other user maybe able to confirm or modify the control parameter adjustment. In othercases, the display of the control parameter adjustment may be presentedfor informational purposes and may not be adjustable by a user. In somecases, the control parameter may be adjusted only after receiving theuser confirmation (e.g., a user interaction with a user interface). Insome other examples, where the adjustment is determined by a computingsystem, the adjustment value may be presented to user via a userinterface of the glucose level control system or a user interface of thecomputing system. In some cases, the user may adjust the controlparameter of the glucose level control system using the adjustment valuereceived from or presented by the computer system.

The adjustment at block 6908 may cause a change in the operation orexecution of the control algorithm. This change in the execution of thecontrol algorithm may result in a change in one or more factorsassociated with the provisioning of therapy to the subject 5804. Forexample, the change in the execution of the control algorithm may resultin a change in an amount of medicament delivered, a timing of thedelivery of the medicament, a rate at which a dose of medicament isdelivered to the subject 5804, a target setpoint or target range for theblood glucose of the subject, a threshold used in determining whether todeliver medicament (e.g., a threshold difference from the targetsetpoint), or any other factor that may affect therapy delivered to thesubject 5804.

In some cases, the adjusted value of the control parameter may be outputto a user (e.g., the subject or a parent). The user may then configurethe glucose level control system 5802 based on the selected controlparameter value. Alternatively, or in addition, the glucose levelcontrol system 5802 may automatically adjust the value of the controlparameter. In some cases, the user may be provided with an opportunityto confirm the adjustment. In other cases, the adjustment may occurautomatically without confirmation. However, the adjustment may bepresented to the user (e.g., the subject or a healthcare provider)and/or logged in a therapy log.

At block 6910, the glucose level control system 5802 provides therapybased at least in part on the updated control parameter that is updatedat the block 6908. The new value of the control parameter may bemaintained during a second time period. The second time period may referto a specific amount of time, an amount of time to deliver a particularnumber of medicament doses, or a particular number of medicament doses.

The process 6900 may be repeated during subsequent time periods. In someexamples, the process may be repeated periodically (every 24 hours,every two days, every week, or other time intervals). In some cases, thetime period may be provided by the subject or a user. Further, theprocess may be repeated in response to a command. In some cases, theprocess may be repeated in response to determining that the subject's5804 blood glucose level does not satisfy one or more criteria for aparticular amount of time. For example, the process may be repeated whena statistically significant difference between the measured mean valueof the BGL and a target BGL exceeds a threshold, or a number ofhypoglycemia and/or hyperglycemia detected exceeds a threshold numberduring a specific amount of time.

In some examples, the process 6900 may be used to adjust several controlparameters that affect the therapy delivery by the glucose level controlsystem. In some such examples, the process 6900 may be used to adjust afirst control parameter during a time period and to adjust a secondcontrol parameter during a second time period. The second time periodmay be immediately after the first time period or delayed by aparticular time. In some implementations, the glucose level controlsystem 5802 may determine when to adjust the control parameter. In someexamples, a delay between periods of control parameter adjustment may bedetermined at least in part on the glycemic control of the glucosesignal. In some cases, the delay may be determined based on inputreceived from a user. Further, the adjustment of the second controlparameter may be at least partially determined based on the determinedadjustment for the first control parameter.

In some embodiments, a third control parameter may be adjusted during athird time period. The adjustment of the third control parameter mayimmediately follow the adjustment of the second control parameter or mayoccur after a delay. The delay may be determined at least in part basedon the glycemic control of the subject after the second controlparameter is adjusted. In some cases, the glucose level control systemmay be configured to sequentially adjust the first and second, or thefirst, second, and third control parameters when the glycemic control ofthe subject satisfies one or more threshold conditions. In someexamples, the duration of the time period during which a controlparameter is adjusted may differ from that of the first and secondcontrol parameters.

As described above, the process 6900 may be used to adjust one or morecontrol parameters that affect the delivery of insulin. However, theprocess 6900 is not limited as such and may be used to modify one ormore control parameters that affect the delivery of other medicaments,such as a counter-regulatory agent (e.g., glucagon). In some cases, theprocess 6900 may be used to recommend a change in insulin and/orcounter-regulatory agent delivery without modifying the delivery. Thiscan be advantageous for generating recommendations regardingcounter-regulatory agent in a non-bi-hormonal glucose level controlsystem 5802 that does not support counter-regulatory agent, or thatsupports the use of counter-regulatory agent, but does not have thecounter-regulatory agent available.

Implementation of Statistical Analysis in Automated Glucose ControlRefinement

As described above, a value (e.g., a baseline value or optimal clinicalvalue) of one or more control parameters of a PK model and/or controlalgorithm used by a glucose level control system 5802 may be determinedby statistical analysis of therapy data sets (e.g., glycemic controlinformation) collected from multiple cohorts of subjects (e.g., 20, 50,100, 200 subjects) during a clinical study. In some examples, thecontrol parameter (e.g., Tmax) may be directly measured for the subjectswithin each cohort (e.g., based on results of blood analysis followingmanual or automated medicament administrations). These measurements maybe used to determine an optimal value of a control parameter (e.g.,Tmax) to be used in a glucose level control system. In some cases, theblood glucose level (BGL) of the subjects may be controlled and recordedfor a given period (e.g., one week, two weeks, one months, or otherperiods) using identical or nearly identical glucose level controlsystems. The subjects in each cohort may use the same values for acontrol parameter of the glucose level control system while the subjectsin different cohorts may use different values of the same controlparameter. Subsequently, the measured therapy data sets, (e.g.,comprising measured and/or determined glycemic control information forthe subjects) over the given period may be compared using statisticalanalysis to evaluate an optimal value of the control parameter. Forexample, the measured glycemic control of subjects in a first cohort inresponse to setting Tmax to a first value, may be compared to themeasured glycemic control of subjects in a second cohort in response tosetting Tmax to a second value. Such comparison may include variousstatistical analysis that can reveal statistically significantdifferences between measured glycemic controls. For example, the meanvalue, variance and/or standard deviation of the measured blood glucoselevel data obtained from the first and second cohort, may be compared toa set of reference values that may be obtained from a third cohort ofsubjects with normal blood glucose level (e.g., nondiabetic subjects).To generate accurate results, such clinical studies often requireseveral cohorts each comprising a large number of subjects (e.g., largeenough to produce enable statistical analysis) and therefore largenumber of identical glucose level control systems. For example, in somestudies 10, 20, 50, or 100 subjects and glucose systems may be required.As such, determining the optimal value of one or more control parametersbased on clinical studies can be expensive and time consuming. Moreover,clinical studies typically cannot capture unique physiologicalcharacteristics of and real-time physiological changes of a subject(even studies include several large cohorts).

A portable glucose level control system that monitors the BGL in realtime and autonomously or automatically provides medicament to a subject,may collect and store therapy data sets that, similar to those collectedin clinical studies, may include sufficient number data points for astatistical analysis. In some examples, therapy data may includeglycemic control information (e.g., received from a CGM sensor), otherphysiological effects of the therapy (e.g., obtained from subjectsensors or the subject), an amount and type of medicament delivered,medicament delivery times, and the like. Advantageously, these therapydata sets may be used to determine an optimal value of one or morecontrol parameters of the glucose level control system or a value forthe one or more control parameters of the glucose level control systemthat provides improved diabetes management compared to a default value,baseline value, or initial clinically determined value. The optimal orimproved values may be determined based on statistical analysis,including the type of statistical analysis that may be used in clinicalstudies. In some embodiments, the statistical analysis may includecalculating one or more statistical quantities such as mean, variance,standard deviation, various statistical distributions (e.g., thosedescribed with respect to FIG. 70 below) and the like. On board andreal-time (or near real-time) evaluation of values of one or morecontrol parameters of a glucose level control system based on therapydata collected during one or more therapy periods eliminates the needfor expensive and time consuming clinical studies and may improve themaintenance of a subject's diabetes by, for example, taking into accountunique physiological characteristics of and real-time physiologicalchanges of a subject. Moreover, on board evaluation of control parametervalues provides for faster and more accurate diabetes evaluation andmanagement compared to clinical testing. Some of the embodimentsdescribed herein may be used to determine optimal values of one or morecontrol parameters that may be used by a user to adjust the controlparameters via a user interface of the glucose level control system. Insome cases, the glucose level control system may autonomously adjust oneor more control parameters using the determined optical values.

The therapy data collected by a glucose level control system may includeglycemic control information, information related to medicament deliverytimes, doses of medicament provided, the BGL level at the time ofmedicament delivery (e.g., measured based on a glucose signal obtainedfrom a CGM sensor), the physiological effects of the medicament on asubject (e.g., BGL in a time period after medicament delivery, subjectsassessment and the like), and any the type of data that may bedetermined from therapy provided to the subject. In some embodiments,the glucose level control system may collect therapy data during one ormore therapy periods. With reference to FIG. 68, the collected andstored therapy data during each therapy period (e.g., a period startingat t_(S) 6804 and ending at t_(E) 6806) may include, but is not limitedto: a Blood glucose level signal G(t) 6802, delivered doses (U_(i) 6808)and delivery times (time t_(u,i)) of insulin, delivered or determineddoses (C_(j) 6814) and delivery times (t_(c,j) 6816), of acounter-regulatory agent (e.g., glucagon) and the like. The therapy datamay be stored in a memory (e.g., a flash drive, a solid-state drive, ahard disk, or any other type of non-volatile memory) of the glucoselevel control system as one or more data sets. Each data set may beassociated with one or more categories of therapy data or a specifictherapy period during which the therapy data was collected. In somecases, the value of the one or more control parameters may change fromone therapy period to another therapy period. For example, the value ofthe control parameter may change by a given amount in the beginning of atherapy period or a group of therapy periods. The value of the controlparameter may be changed automatically by the glucose level controlsystem 5802 or by a user via a user interface. In some cases, thecontrol parameter may be changed by a given amount after certain numberof therapy periods. The amount by which the control parameter is changedmay be determined based on therapy data collected during one or morepreceding therapy periods. Alternatively, or in addition, the amount bywhich the control parameter is changed may be provided by a user via auser interface. In some cases, the duration of one or more therapyperiods is selected such that the measured or determined data sets aresufficiently large for statistical analysis. In some examples, anuncertainty associated with an optimal or improved value of a controlparameter determined using statistical analysis may depend on the sizeof the data set used for the analysis.

In some embodiments, the process 6600 may be used to determine a value(e.g., an optimal value) of a control parameter using statisticalanalysis. For example, statistical analysis may be used to determine thetherapy effects at block 6606, block 6614, or to compare the therapyeffects resulting from different control parameter values at step 1316.In some such examples, at block 6608, the second value of the controlparameter may be provided by the user (e.g., the subject or theguardian) based at least in part on the first effect and outcomes of thestatistical analysis performed on the therapy data collected and/orstored during the first therapy period (block 6604). In some examples,at block 6616, a statistical analysis may be performed based at least inpart on the first effect and the second effect to obtain a comparativeassessment. The comparative assessment may be used to determine whetherone of a pair or set of values of a control parameter results in animproved glycemic control of the subject compared to the other valuesused for the control parameter. In some embodiments, the determinedvalue of the control parameter at block 6616 may be provided to thesubject, a guardian or a healthcare provider via a user interface of theglucose level control system 5802 and/or a computing system (e.g., asmartphone, a notebook a personal computer and the like) connected tothe glucose level control system (e.g., via a wireless link). In somesuch embodiments, the subject, the guardian or the healthcare providermay change the value of the corresponding control parameter to thedetermined value by an interaction with a user interface before the nexttherapy period (e.g., at block 6618). Alternatively, or in addition, theglucose level control system 5802 may automatically change value of thecontrol parameter to the determined value and proceed to block 6618. Insome such cases, the user may be provided with an opportunity to confirmthe modification. In other cases, the modification may occurautomatically without confirmation. However, the modification may bepresented to the user (e.g., the subject or a healthcare provider)and/or logged in a therapy log.

In some examples, the first and second therapy provided to the subjectduring the first (block 6604) and second (block 6612) therapy periods,may include a plurality of therapy deliveries. During the first (block6604) and second (block 6612) therapy periods, a first and second firsttherapy data may be obtained by the glucose level control system 5802.In some such cases, the therapy data may comprise glycemic controlinformation that at least includes the glucose signal received duringthe corresponding therapy period. Determining the first effect mayinclude calculating statistical characteristics of the therapy datacollected during the plurality of therapies provided during each period.For example, the control system 5802 may calculate the mean value,deviation from mean value, and the variance of the measured BGL. In somecases, the glucose level control system 5802 may calculate one or morequantities (e.g., statistical quantities) to quantify the average bloodglucose level and its deviation from a baseline level. In someembodiments, the glucose level control system 5802 may determine one ormore quantities (e.g., statistical quantities) to evaluate thevariability of glycemic control and the associated risks (e.g., risk ofhypoglycemia or hyperglycemia) or quantify the average blood glucoselevel and its deviations from a baseline (e.g., normal) level. In somecases, the duration of the second period may be equal to the duration ofthe first period. Alternatively, or in addition, the duration of eachperiod may be selected such that each period includes the same number oftherapies provided to the subject. In some embodiments, the duration ofeach period may be selected such that the number of times therapy isadministered during the time period is large enough to enablestatistically significant assessments. In some cases, at block 6616, thecomparison between the first effect and the second effect, may includestatistical analysis of statistical data generated based on the datacollected during the first and second period.

In some examples, in addition to the optimal values of one or morecontrol parameters, the control system may generate a control parameteroptimization report that may include the statistical quantitiescalculated during the optimization process. Further, the report mayinclude a graphical representation of the therapy data and related riskassessments. In some such examples, this report may be used by thesubject or a healthcare provider to make decisions related to selectinga determined optimal parameter value. Additionally, the controlparameter optimization report may include information that may be usedby the subject or a healthcare provider to modify the overall strategyfor managing the subject's glycemic control. For example, modifying themealtime, content or amount of meal consumed by the subject, and thelike.

FIG. 70 illustrates some examples of statistical quantities that may begenerated and utilized at blocks 6606 and 6614 of the process 6600,using the therapy data 7006 during a therapy period, and knownparameters of the control system 7004. In some embodiments, during thetherapy period the value of certain control parameter may be fixedand/or selected based on baseline values (e.g., outcomes of previousclinical studies) or a previously determined value (e.g., by a differentcontrol parameter modification and/or optimization process). Withreference to FIG. 68, in the example shown in FIG. 70, G_(min) 7018(lower bound for normal BGL), G_(max) 7016 (upper bound for normal BGL)and G_(set) 7020 (target BGL) are assumed to be known values provided bythe subject, the user, a health care provider or determined by acomputing system based on a set of clinical data. For example, G_(min)7018 may between 65 mg/dL and 75 mg/dL, G_(max) 7016 may be between 175mg/dL and 185 mg/dL and G_(set) 7020 may be between 70 mg/dL and 180mg/dL. In some examples, G_(set) 7020 may be a value (e.g., an optimal)determined by a previous optimization process (e.g., the process 6600).G(t) 7002 (the CGM trance or the measured glycemic control), U_(i)'s7008, t_(u,i)'s 7010, C_(j)'s 7012 and t_(c,i)'s 7014 may be included inthe therapy data collected during the therapy period. In some examples,the therapy data 7006 may be used to generate various types ofstatistical quantities. For example, the therapy data 7006 may be usedto generate probability distributions (e.g., discrete or continuous)and/or frequency distributions (e.g., absolute, relative, or cumulative)for certain measured or determined values. For example, thedistributions associated with the glucose concentration 7022 (e.g.,portions of the therapy period during which the glucose signal waswithin selected ranges), glucose change rate 7026 (e.g., portions of thetherapy period during which the glucose change rate signal was withinselected ranges rates), insulin dose 7028 (percent of insulin dosesprovided within selected dose ranges), glucagon dose 7030 (percent ofglucagon doses provided within selected dose ranges), hyperglycemia 7032(percent of hyperglycemia events detected wherein the glucose signal wasabove G_(max) by an amount within selected ranges), hypoglycemia 7024(percent of hypoglycemia events detected wherein the glucose signal wasbelow G_(min) by an amount within selected ranges) and the like. In someexamples, one or more characteristic of these statistical distributions(mean, variance, deviation from mean, and the like) or a specificcombination of some characteristics of these statistical distributions,may be used to determine (e.g., quantify) the effect of a therapy. Insome examples the therapy data considered to generate certainstatistical data (e.g., a histogram) may be filtered to exclude the datapoints collected during certain events. For example, during a mealtime,during exercise, and the like. In some examples, time bins associatedwith these events may be specified by a user through a user interface.

In some embodiments, the statistical analysis may comprise analyticalmethods and tools that can compare the effect of different controlparameter values. Some examples of analytical methods and tools that canbe used with one or more of the embodiments described herein aredescribed in the article “Statistical Tools to Analyze ContinuousGlucose Monitor Data” (W. Clarke et al., Diabetes Technology andTherapeutics, vol. 11, S45-S54, 2009), which is hereby incorporated byreference in its entirety herein. Examples of methods and tools that mayfacilitate extraction of information from complex and voluminousmeasured glycemic control information during therapy periods, arediscussed herein. In some cases, the therapy data used for statisticalanalysis includes the glucose trace of the subject or G(t). In someexamples, G(t) may be a time-stamped series of glycemic data receivedfrom a CGM sensor (see FIG. 70). In some examples, the glucose signalobtained from CGM may represent blood glucose level as a discrete timeseries that approximates G(t) in steps determined by the resolution ofthe particular device (e.g., a reading every 2 min, 5 min, 10 min andthe like). In some examples, statistical analysis may be performed onthe therapy data (e.g., the glucose signal received from a CGM sensor)to provide an assessment (e.g., a comparative assessment) related to:(1) average blood glucose level and deviations from normal glycemiccontrol (sometimes referred to as normoglycemia), (2) variability andrisk assessment, and (3) clinical events, such as post-meal glucoseexcursions and hypoglycemic episodes. In some embodiments, theassessment may be made based on two sets of therapy data collectedduring two time periods. In some such examples, the assessment may beused by the glucose level control system 5802 to determine whether theglycemic control for a subject has been improved from a first therapyperiod to a second therapy period. In some examples, the assessment maybe used by a health care provider to evaluate the glycemic control of asubject during one or more time periods.

In some cases, the glucose level control system may determine threevalues of average blood glucose: the mean value (e.g., computed for theentire G(t) measured during a therapy period or part of a therapyperiod), a pre-meal mean value (e.g., computed for the time window of60-120 min after the meal), and post-meal mean value (e.g., computed forthe time window of 0-60 min before meal). Computing of pre- andpost-meal averages and the difference between the averages can serve asan indication of the overall effectiveness of pre-meal bolus timing andbolus amount. In some examples, deviation from target or normoglycemiamay be evaluated by determining percentages of time spent within, below,or above preset target limits (e.g., G_(min)=70 and G_(max)=180 mg/dL).In some examples, the percentage of time within each range may becalculated via linear interpolation between consecutive glucosereadings. In some other examples, percentage of time within additionalranges can be computed. In some such examples, the probability ofoccurrence of extreme hypoglycemia and hyperglycemia may be alsoevaluated. To quantify variability of blood glucose level, in someexamples, standard deviation and variance may be used to computevariability of BGL. In some cases, a risk index may be defined that canserve as a measure of overall glucose variability when focusing of therelationship between glucose variability and risks for hypo- andhyperglycemia. In some examples, an individual function may becalculated to split the overall glucose variation into two independentsections related to excursions into hypo- and hyperglycemia, and at thesame time equalize the amplitude of these excursions with respect to therisk they carry. For example, a BGL transition from 180 to 250 mg/dL mayappear threefold larger than a transition from 70 to 50 mg/dL, whereasif converted into risk, these fluctuations would appear equal. In somecases, analysis of BGL rate of change (e.g., measured in mg/dL/min) maybe used to evaluate the dynamics of BGL fluctuations on the time scaleof minutes. In other words, this is an evaluation of the “local”properties of the system as opposed to “global” properties discussedabove. In some examples the local properties may be assessed at aneighborhood of any point in time by the value BGL, its first or,sometimes, second derivatives (acceleration).

In some examples, in addition to statistical analysis of the therapydata, in the blocks 6606, 6614, and 6616 of the process 6600, astatistical analysis of the user inputs provided during the first orsecond therapy period may be used in determining or comparing thetherapy effects. For example, the number of times and time of the daythat the subject has indicated certain symptoms, may be used todetermining therapy effects.

In some cases, in addition to the statistical analysis of the therapydata in the blocks 6606, 6614, and 6616 of the process 6600, astatistical analysis of the biomedical or physiological data receivedfrom one or more subject sensors (e.g., a smart watch, weight sensor,etc.) may be used in determining or comparing the therapy effects. Forexample, subject's temperature, blood pressure, heart rate), from aweight sensor, or any other type of biomedical sensor.

In some examples, the process 6600 may be modified to determine theoptimal value of Tmax, or a value of Tmax that provides improvedmaintenance of the subject's diabetes, by reducing Tmax (increasing theaggressiveness of the therapy) after each therapy period in a series oftherapy periods, until a statistical assessment shows that furtherreduction of the Tmax does not improve the mean glucose level withoutincreasing the probability of hypoglycemia. Improved maintenance of thesubject's diabetes may include maintaining a mean glucose level closerto a setpoint glucose level range or reducing fluctuations in meanglucose level over time compared to prior control value (e.g., Tmax)settings. It should be understood that other metrics may be used tomeasure an improvement of maintenance of the subject's diabetes, such asreduction in hypoglycemia risk events or reduction in administration ofinsulin without increasing diabetic effects or corresponding risks.

FIG. 71 presents a flowchart of an example automated control parameterrefinement process 7100 in accordance with certain embodiments. Theprocess 7100 may be performed by any system that can autonomously and/orautomatically modify a control algorithm and/or a control parameter thataffects execution of the control algorithm based on feedback (e.g., froma blood glucose signal) relating to therapy administered to a subject5804. For example, the process 7100 may be performed by one or moreelements of the glucose level control system 5802. In some cases, atleast certain operations of the process 7100 may be performed by aseparate computing system that receives blood glucose data from theglucose level control system 5802. Although one or more differentsystems may perform one or more operations of the process 7100, tosimplify discussions and not to limit the present disclosure, theprocess 7100 is described with respect to particular systems.

The process 7100 may be performed automatically and without userinteraction. In some cases, a user may trigger the process 7100 via acommand or interaction with a user interface. However, once the process7100 is triggered, the process 7100 may be performed automatically.Further, the process 7100 may be performed continuously, periodically,or in response to a trigger. The trigger may be time based and/or basedon a measurement of the glucose level of the subject. For example, thetrigger may correspond to a determination that a glucose level of asubject differs by more than a threshold from a predicted glucose levelthat is predicted by a glucose level control algorithm based on theadministering of medicament. Further, the trigger may be based on theactivation or first time use of the glucose level control system 5802 bythe subject 5804.

In some embodiments, the glucose level control system 5802 may performthe process 7100 in order to adjust one or more control parameters ofthe glucose level control system 5802 to improve the glycemic control ofa subject. The control parameter may include any control parameter thataffects operation of the glucose level control system 5802 and/orperformance of a control algorithm of the glucose level control system5802. In some such embodiments, in addition to improving the glycemiccontrol of the subject, the process 7100 may take into account the riskof hypoglycemia in the subject. In some embodiments, the process 7100may include one or more of the embodiments previously described withrespect to the process 6600.

The process 7100 begins at block 7102 where an initial value is selectedfor a control parameter of the glucose level control system (e.g., Tmaxor other control parameters of the glucose level control system selectedto be optimized). The control parameter can be a control parameter of apharmacokinetic (PK) model used by a control algorithm PK of the glucoselevel control system 5802. In some examples, the control parameter maybe a time until insulin within blood plasma of the subject reaches aparticular concentration level subsequent to administration of aninsulin dose. In some cases, the initial value of the control parametermay be based on therapy delivered during a time period prior to thefirst therapy period, a clinical value, or a body mass of the subject.

In some examples, the initial value of the control parameter may beselected using one or more of the embodiments described with respect tothe block 6604 of the process 6600. In some embodiments, the controlparameter may be a control parameter used by the control algorithm ofthe glucose level control system to account for accumulation of insulinin a subject. In some embodiments the control parameter may be used tocontrol an insulin dosing response of the control algorithm to a bloodglucose excursion in the subject based on a glucose level signalreceived from a glucose level sensor (e.g., a SGM sensor).

At block 7104, the glucose level control system 5802 may provide therapyduring a first therapy period based at least in part on the glucoselevel signal and the initial value of the control parameter. In certainembodiments, the block 7104 can include one or more of the embodimentspreviously described with respect to the block 6604 of the process 6600.In some embodiments, the first therapy data may include glycemic controlinformation resulting from the delivery of the first therapy. In someexamples, the system may store all or some of the therapy data generatedduring the first therapy period in a memory of the glucose level controlsystem 5802. In some examples, the therapy provided at block 7104, maycomprise a plurality of medicament deliveries.

At block 7106, the glucose level control system 5802 may determine thetherapy effect of the therapy provided during the first therapy periodusing statistical analysis of the first therapy data collected andstored at block 7104. In some examples, the statistical analysis mayinclude calculating the statistical quantities discussed above and withreference to FIG. 70. In some cases, the statistical analysis mayinclude regression analysis between certain measured and/or calculatedparameters at block 7104. In some such examples the regression analysismay include determining an autoregression model. In some examples, theglucose level control system 5802 may determine the therapy effect usingone or more of the embodiments described with respect to the block 6606of the process 6600.

At block 7108, the glucose level control system 5802 may modify thevalue of the control parameter compared to the initial value selected atblock 7102 or the value used in the last therapy period. In someexamples, the modified value may be a value that makes the therapy moreaggressive (e.g., aggressive by a significant amount). For example, whenthe control parameter is Tmax, at block 7108 the value of Tmax may bereduced to an amount less (e.g., 5, 10, 15 minutes, or more) than thevalue used in a previous therapy period (e.g., the initial value or thelast modified value). In some examples, the modified value of thecontrol parameter may be received from a user interface of the glucoselevel control system responsive to a user interaction with the userinterface. The previous therapy period may be the first therapy periodor any earlier therapy period. In some examples, the value for Tmax maybe lowered by a significant amount (e.g., 10 minutes, 15 minutes, orother values). Further, the amount by which Tmax is reduced may besmaller than a previous reduction during a previous iteration of theprocess 7100. In some embodiments, the control parameter may be modifiedautomatically without action by a user. In some cases, modifying thecontrol parameter may change a timing, a dosage size, or a speed ofinjection of insulin administered to the subject.

At block 7110, the glucose level control system 5802 provides therapy tothe subject based at least in part on the glucose signal and themodified value of the control parameter received from block 7108. Insome examples, the duration of the therapy period (at block 7110), maybe equal to the duration of one or more previous therapy periods. Insome other examples, the duration of the therapy period may bedetermined based on the determined therapy effects of the therapiesdelivered during one or more previous therapy periods. In some examples,at block 7110 the system may store all or some of the therapy datagenerated during the therapy period. In some examples, the therapyprovided at block 7110, may comprise a plurality of medicamentdeliveries. In some cases, the therapy data may include glycemic controlinformation resulting from the delivery of the therapy.

At block 7112, the glucose level control system 5802 determines thetherapy effect of the therapy provided at block 7110 during the lasttherapy period. In some examples, the therapy effects may be determinedbased at least in part on the therapy data obtained and stored at block7110. In some examples, the glucose level control system 5802 maydetermine the therapy effect using one or more of the embodimentsdescribed with respect to the block 6606 of the process 6600.

At block 7114, the glucose level control system 5802 performs astatistical analysis based at least in part in the determined therapyeffect of the therapies provided and stored during the last therapyperiod and the therapy period before the last therapy period to obtain acomparative assessment. In some such examples the comparative assessmentmay be based on statistical analysis of determined effects and thetherapy data collected during the corresponding therapy periods. In someexamples, the statistical analysis may include generating statisticalquantities (e.g., distributions shown in FIG. 70) using the therapydata. In some examples, the statistical analysis may include theanalytical method described above. In some such examples, one or morecharacteristics of the statistical data may be used to compare thetherapy effects. In some examples, the statistical analysis may includecalculating one or more of a mean, a median, a mode, a standarddeviation, a rate, a ratio, or a probability based on the therapy dataobtained in the last two therapy periods or the determined effects ofthe therapies provided during the last two periods.

At the decision block 7116, the glucose level control system 5802, basedat least in part on the comparative assessment received from block 7114,the glucose level control system 5802 may determine whether the value ofthe control parameter used during the last therapy period has improvedthe glycemic control for the subject compared to the therapy periodbefore the last therapy period. In some embodiments, the glucose levelcontrol system 5802 may determine whether the modified value for thecontrol parameter has resulted in statistically significant improvementin glycemic control. In some embodiments, the glucose level controlsystem 5802 may determine whether the modified value for the controlparameter has resulted in an improvement of a physiological parameter ofthe subject. In these embodiments, the physiological parameter may bedetermined based at least in part on the glucose level signal receivedfrom a glucose level sensor.

If the glucose level control system 5802 determines at the decisionblock 7116 that the glycemic control for the subject is not improved,the glucose level control system 5802 may return to the block 7110 andcontinue providing therapy to the subject based on the last modifiedvalue of the control parameter without any further modification.

If at the decision block 7116 the glucose level control system 5802determines that the value of the control parameter used during the lasttherapy period has improved the glycemic control for the subjectcompared to the therapy period before the last therapy period, theglucose level control system 5802 proceeds to decision block 7118. Insome cases, the improvement in the glycemic control should be largerthan a threshold level before the glucose level control system 5802proceeds to decision block 7118. In some cases, the control systemproceeds to decision block 7118 if the modified value of the controlparameter results in a reduced occurrence of blood glucose excursionscompared to the first value of the control parameter.

At decision block 7118 the glucose level control system 5802 maydetermine whether the frequency and/or severity of hypoglycemia eventsis increased during the last therapy period compared to the therapyperiod before the last therapy period. In some examples, if the glucoselevel control system 5802 determines that the frequency and/or severityof hypoglycemia events is increased (e.g., beyond a threshold number oramount) during the last therapy period, the glucose level control system5802 may return to the block 7110 and continue providing therapy to thesubject based on the last modified value of the control parameterwithout any further modification. If at decision block 7118, the controlsystem determines that the change in frequency and/or severity ofhypoglycemia events is negligible (e.g., below a threshold number oramount), the control system may proceed to the block 7108 where theglucose level control system 5802 modifies the value of the controlparameter. In some examples, the modified value may be a value thatresults in more aggressive therapy (e.g., the value of Tmax may bereduced). In some such examples, the amount by which the controlparameter is changed may be smaller than a reduction amount in one ormore previous modifications.

In some examples, at the decision block 7118 the control system maydetermine risks or the frequency and severity of one or more eventsother than hypoglycemia. For example, the control system may determinethat in spite of an improvement in glycemic control for the subject, therate and magnitude of glucose concentration has increased beyondthreshold value. In some such examples, these additional riskdeterminations may be used to determine whether to keep or modify thelast value of the control parameter.

In some embodiments, a modified version of the process 7100 may be usedby the glucose level control system wherein the process stops atdecision block 7116 and the control system continues providing therapybased on the last modified value of the control parameter until a userinput is received. In some such examples, the last value of the controlparameter (modified at block 7108), the results of the comparativeassessment generated based on the comparison performed at block 7114(e.g., whether a statistically significant improvement in subject'sglycemic control resulted from the last control parameter change), maybe output to the subject, a guardian or a healthcare provider via a userinterface of the glucose level control system 5802 and/or a computingsystem (e.g., a smartphone, a notebook a personal computer and the like)connected to the glucose level control system (e.g., via a wirelesslink). In some such embodiments, at least in part based on the outcomesof the comparative assessment, the subject, the guardian or thehealthcare provider may change the value of the corresponding controlparameter (e.g., an interaction with a user interface) before the nexttherapy period.

In some examples, the statistical analysis used to determine the therapyeffects (e.g., at blocks 6606 and 6612 in the process 6600, and block7106 and 7112 in the process 7100) or to compare between therapy effects(e.g., at block 6616 in the process 6600 and block 7114 in the process7100), may include regression analysis. In some examples, regressionanalysis may be used to find a relation between parameters calculatedand/or measured during the therapy period. For example, with referenceto FIG. 70, a regression analysis may be used to find a relation betweenU_(i) and the rate of glucose concentration change (e.g., using G(t)near t_(i)) for a plurality of therapies provided during a therapyperiod. In some cases, the outcomes of one or more regression analysismay be used in the optimization process to determine a value of thecontrol parameter.

In some examples, the therapy data captured and stored during one ormore therapy periods may be divided to equal time intervals wherein eachtime interval starts and ends at substantially the same specific startand end times within a 24 period. In some such examples, anautoregression model may be derived for the glycemic control over thetime interval between the specific start and end times. Subsequently,the resulting autoregression model may be used to determine whether theglycemic control has been improved compared to a previous therapyperiod. In some cases, the resulting autoregression model may be used tomake additional adjustments to one or more control parameters in thesubsequent therapy periods (after therapy periods following the periodin which an autoregression model is determined).

In some examples, the outcome of the statistical analysis of therapydata may be used to evaluate the accuracy glucose signal generated by aCGM sensor.

As mentioned above in some examples the glucose level control system maygenerate a control parameter optimization report that may include someor all of the statistical quantities calculated during the optimizationprocess, outcomes of the statistical analysis and graphicalrepresentation of the therapy data and related risk assessments. In somesuch examples, a Control Variability-Grid Analysis (CVGA) may beincluded in the control parameter optimization report, to visualize thevariability of CGM data at a group level from a glucose-control point ofview. In some examples the graphs may comprise distinctive groups ofgraphs, for example, to visualize average glycemia and deviations fromtarget values, visualize variability and risk assessment, andevent-based clinical characteristics. In some other examples, thegraphical data may represent average glycemia and deviations from targetglucose trace and aggregated glucose trace representing the time spentbelow, within or above the preset target range and visualizing thecrossing of glycemic thresholds. In yet other examples, the controlparameter optimization report may include graphs representingvariability and risk assessment data. For example, a risk trace may bepresented to highlighting essential variance (e.g., by equalizing thesize of glucose deviations towards hypo- and hyperglycemia, emphasizinglarge glucose excursions, and suppress fluctuation within target range).In some other examples, histogram of blood glucose rate of change may beincluded in the report to presented, for example, the spread and rangeof glucose transitions. In yet other examples, Poincare′ plots may beincluded in the report to visualize the stability of the glucose signalduring different therapy periods that may be also associated withdifferent values of a control parameter.

Embodiments of High Dose Mode

An automated glucose level control system, such as the glucose levelcontrol system 5802, can adjust a subject's glucose level over time byadministering medicament, such as insulin or a counter-regulatory agent(e.g., glucagon). It is generally desirable that the glucose level bemaintained within a setpoint range that is optimal for maintaining thesubject's health or controlling the subject's disease (e.g., diabetes).Using one or more of the 510, the glucose level control system 5802 canadjust the subject's glucose level to be within the desired glucosesetpoint range. In certain embodiments, the control algorithm used bythe one or more controllers 5810 may adapt over time to control thesubject's glucose level more smoothly or such that there is less dynamicrange in the subject's glucose level. In other words, the controlalgorithm can be adapted over time so that the subject's glucose levelis maintained within a more consistent range. It is typically desirableto not only maintain the subject's glucose level within a desiredsetpoint range, but to also limit fluctuations or large fluctuations inglucose level. It should be understood that some fluctuations may occureven in a completely healthy individual as meals and daily life (e.g.,sleep, exercise, etc.) may affect glucose level of a subject. However,it is typically desirable to limit fluctuations of glucose level that gobeyond that of a healthy or disease-free subject. The ability of theglucose level control system 5802 to adapt the control algorithm foradministering medicament helps maintain the subject's glucose levelwithin the desired setpoint range. A number of control algorithms thatcan be implemented by the glucose level control system 5802 describedherein are described in the following patents that are herebyincorporated by reference herein in their entirety and made a part ofthis application: U.S. Pat. No. 7,806,854, issued Oct. 5, 2010; U.S.Pat. No. 9,833,570, issued Dec. 5, 2017; U.S. Pat. No. 10,543,313,issued Jan. 28, 2020; U.S. Pat. No. 10,842,934, issued Nov. 24, 2020;and U.S. Pat. No. 10,940,267, issued Mar. 9, 2021. It should beunderstood that the glucose level control system 5802 may implementother control algorithms instead of or in addition to the controlalgorithms described in the aforementioned patents.

However, there are times when the amount of time to adapt a subject'sglucose level is less than ideal. In some cases, the control algorithmsthat control the administering of medicament may take longer to adaptfor subjects with higher insulin per body mass or weight (e.g., per kg)requirements. Further, there are times when an adapted control algorithmis no longer applicable or well-adapted to the subject. In other words,there are times when the glucose level of the subject may be lessconsistent and may include more fluctuations. For example, a subjectwhose body is going through significant physiological changes (e.g.,puberty, large or rapid weight change, sickness, etc.) may result inlarger glucose level fluctuations or for an adapted control algorithm tono longer be well-adapted to the subject. As another example, unusualactivity (e.g., a heavy or significant exercise session for a subjectthat usually does not exercise) may result in fluctuations in glucoselevel of the subject. Over time, the control algorithm will adapt to thephysiological changes or other causes of glucose level fluctuations inthe subject. However, while the control algorithm is adapting, glucosecontrol may fluctuate more and/or maintenance of the subject's diseasemay be suboptimal.

In certain embodiments, providing different operating modes for one ormore of the glucose level controllers 5810 that provide for differentdosing modes and/or adaptation ranges for the glucose control algorithmof the ambulatory medical device Acan reduce the time to adapt thecontrol algorithm used to control administering of medicament to thesubject. In other words, while a one size fits all may take varyingamounts of time to adapt glucose control for different subjects, the useof different operating modes that may be selected based on one or morephysiological characteristics (e.g., weight, sex, age, sensitivity toinsulin, sensitivity to glucose, etc.) of the subject can reduce theadaptation time of the control algorithm for certain subjects. Further,the use of different operating modes can reduce fluctuations in glucoselevel of the subject. Having different operating modes with differentadaptation modes enables the glucose level control system to narrow orwiden the adaptation range based on one or more characteristics of thesubject, which may be determined by the ambulatory medical device, ahealthcare provider, a subject, or other user. In some cases, adjustingthe adaptation range may adjust the quantity of dosing, the timing ofdosing, the frequency of dosing, or any other factor associated with theadministering of medicament to the subject. For example, one operatingmode may be a high dose mode that results in larger doses of medicamentbeing administered with each bolus of medicament and/or within aparticular time period compared to a normal or non high dose mode.

In some embodiments, providing different operating modes for the glucoselevel controllers 5810 may include providing different adaptation rangesand/or different levels of aggressiveness for adjusting one or morecontrol parameters of a control algorithm that generates control signalsfor controlling the administration of medicament to the subject. In somecases, the operating mode may be adjusted from an operating modeassociated with a particular adaptation range or aggressiveness toanother operating mode associated with a different adaptation range oraggressiveness. For instance, if a physician or healthcare providerknows that a subject needs on average more insulin than a particularthreshold, the ambulatory medical device may be configured (e.g., by thehealthcare provider) to permit a user to adjust the mode of operation tolimit or adjust the range of the aggressiveness control parameter (e.g.,by eliminating half of the adaptation range). The mode can be activatedby interacting with a user interface element of the ambulatory medicaldevice (e.g., by selecting a switch, pushing a button, interacting witha touch screen, causing a command to be transmitted to the ambulatorymedical device from another electronic device, etc.).

Further, in some cases, statistical analysis of glycemic control can beused to determine whether a particular operating mode, such as a highdose mode is appropriate. In some such cases, the ambulatory medicaldevice may be able to monitor one or more control parameters andrecommend high dose mode, or a non high dose mode, based at least inpart on the adapted values for the one or more control parameters.

In some instances, a subject or user may desire to invoke an operatingmode (e.g., a high dose mode) for a subset of available controllers. Forexample, the subject or other user may desire to invoke a high dose modefor a model predictive controller (e.g., the corrective insulincorrective insulin controller 5906) that controls correction boluseswhile maintaining a basal controller (e.g., the basal insulin controller5904) and/or meal controller (e.g., the priming insulin controller 5908)in a normal or non high dose mode. In certain embodiments, the subjector user may separately set operating modes for each controller of theglucose level controllers 5810. Further, in instances where operatingmodes are set automatically, the ambulatory medical device AMD mayseparately set the operating mode for each controller of the glucoselevel controllers 5810. In other words, one or more controllers thatcontrol administering correction doses, basal doses, and/or meal dosesmay individually or collectively be configured to operate in high dosemode or non high dose mode.

Configuration Code

The learning aspects of the adaptive control algorithms for medicamentadministration can be built up over an extended period of time. Thislearning can be lost if the glucose level control system becomesdisabled, unusable, or a subject otherwise needs to begin therapy usinga different glucose level control system. While a subsequent glucoselevel control system can include the ability to re-learn thephysiological responses of the subject and the resulting therapyparameters, as described above, this process can take time. Accordingly,it can be advantageous to capture some or all of the glucose levelcontrol system parameters (GLCSP) provided to a subject by a previouslyused glucose level control system. The GLCSP parameters can be providedas initial therapy parameters to subsequently used glucose level controlsystems. The provided therapy parameters can “jump start” at leastinitial therapy provided by the subsequent glucose level control system.

The GLCSP, which may include dosing parameters, setting parameters,and/or control parameters of the adaptive algorithm, can be generated bythe glucose level control system in the form of a configuration code.The GLCSP can generally include any configuration or setting of theglucose level control system (e.g., control parameters such as weightthat influence correction factor, carb ratio, basal rate, etc.). Theconfiguration code can be used when a glucose level control system isreplaced with another glucose level control system. The configurationcode can customizes at least initial therapy provided by a glucose levelcontrol system.

FIG. 72 presents a flowchart of an example configuration code generationprocess 7200 in accordance with certain embodiments. The process 7200may be performed by any system that can track medicament therapy (e.g.,insulin or glycogon therapy) provided to a subject over time or systemwith access to data based on the tracked medicament therapy. The process7200 generates a configuration code that may be used if a glucose levelcontrol system (e.g., glucose level control system 5802) requirescustomization for a subject (e.g., because the becomes an existingglucose level control system unavailable). For example, the process 7200may be performed by one or more elements of the glucose level controlsystem 5802.

In some cases, at least certain operations of the process 7200 may beperformed by a separate computing system that receives indications ofmedicament therapy provided to the subject 5804 from the glucose levelcontrol system 5802. Although one or more different systems may performone or more operations of the process 7200, to simplify discussions andnot to limit the present disclosure, the process 7200 is described withrespect to a glucose level control system 5802. However, other systems,such as cloud-based or other type of remote computing systems mayperform the process 7200 to generate and output the configuration code.

At block 7202, the glucose level control system 5802 tracks medicamenttherapy administered to the subject 5804 over a tracking period. Thetracking period is typically at least one day and may be longer. Forexample, the tracking period may be 1 day, 2 days, a week, a month,several months, a year, any length of time between the foregoingexamples, or even longer. In some cases, the tracking period may becontinuous from a point in time when tracking begins. For example, thetracking period may encompass the entire usage lifetime of the glucoselevel control system 5802 by the subject 5804. In cases where thetracking period is set for a defined period of time (which may bemodified for different iterations of the process 7200), the process 7200may be repeated periodically, upon request, or upon a triggering eventusing a new tracking period, of equal or different length. Thetriggering event may include any event that may render a prior generatedconfiguration code potentially out-of-date. For example, the triggeringevent may include a change in medicament type (e.g., differentmedicament or counter-regulatory agent formulations), a change inphysiological characteristics of the subject 5804 (e.g., a change inweight, or sensitivity to different glucose levels or medicament), or achange in average activity level of the subject 5804.

In some cases, the tracking period may be defined by or based on aparticular number of medicament administering events. For example, thetracking period may be defined by at least ten instances of generatingan medicament dose based on a glucose level signal. As another example,the tracking period may be defined by a minimum number of meal events,correction dose events, and/or basal dose events. For instance, thetracking period may require 3 meals, or 3 meals of each meal type tooccur, 2 correction doses, and/or basal doses. It should be understoodthat the aforementioned number of doses is just an example, and thetracking period may include more or fewer dose amounts. Moreover, thetracking period may be defined or specified as a combination of time andoccurrences of a particular number of doses of medicament.

In some cases, the tracking period may be variable. For example, if theglucose level control system 5802 determines that the medicament dosetherapy is inconsistent or erratic over the tracking period (e.g., dueto inconsistent exercise or eating habits), the tracking period may beextended.

Tracking the medicament therapy includes storing an indication of dosesof medicament delivered to the subject as correction boluses ofmedicament, as food intake boluses of medicament, as basal doses ofmedicament, and/or other parameters such as those described below. Thecorrection boluses can include regulatory or counter-regulatory agentsand can be generated using a model-predictive control (MPC) algorithmsuch as the one disclosed in the Controller Disclosures described above.The meal boluses can include a regulatory agent and can be generatedusing a meal control algorithm such as disclosed in the ControllerDisclosures. The basal doses can include a regulatory agent and can begenerated using a basal control algorithm such as disclosed in theController Disclosures. Storing the medicament dose control signaland/or the indication of the quantity of medicament may include storingthe medicament dose control signal and/or the indication of the quantityof medicament in a therapy log or any other type of data structure inthe memory 5830 of the glucose level control system 5802.

Tracking the medicament therapy may include storing the medicament dosecontrol signal generated based at least in part on a glucose levelsignal. The glucose level control system 5802 can receive a glucoselevel of a subject 5804, which may include receiving and/or determininga glucose level signal corresponding to a glucose level of the subject.The glucose level signal may be received from the glucose sensor 5808(e.g., a CGM sensor). Alternatively, or in addition, the glucose levelmay be received from a user that provides the glucose level to theglucose level control system 5802 via a user interface, such as a userinterface generated by the separate processor 5820 that may be output ona touchscreen by the touchscreen controller 5828. The glucose levelreceived from the user may be a glucose level measured using analternative sensor or measurement mechanism (e.g., diabetes measurementstrips) that may be used in place of the glucose sensor 5808. Theglucose level control system 5802 generates an medicament dose controlsignal based at least in part on the glucose level signal. In somecases, the medicament dose control signal may be a medicament controlsignal configured to control a medicament pump to administer medicament(e.g., medicament, counter-regulatory agent, or other medicament) to asubject 5804. The dose control signal may be generated using a controlalgorithm configured to autonomously determine doses of medicament to beadministered to or infused into the subject for the purpose ofcontrolling blood glucose of the subject based at least in part on theglucose level or glucose level signal.

Alternatively, or in addition, the glucose level control system 5802 maystore the medicament dose control signal and/or the indication of thequantity of medicament at a remote data store location. This remote datastore may be a computing system with which the glucose level controlsystem 5802 may communicate (e.g., a laptop, desktop, smartphone, orother computing device of the subject 5804 or a user). The glucose levelcontrol system 5802 may provide the medicament dose control signal dataor the indication of the quantity of medicament to the local computingsystem via Bluetooth®, near field communication services, or via a localnetwork. Alternatively, or in addition, the remote data store may be aremote computing system that the glucose level control system 5802 maycommunicate with over a wide area network, such as a wireless areanetwork, a cellular network using IoT based communication technology,cellular communication technology, or any other communication network.In some cases, the wide area network may include the Internet. Theglucose level control system 5802 may include a wireless radio thatenables it to communicate with the local or remote computing system.Further, the remote computing system may be a computing system of a datacenter or a cloud computing environment.

Whether a local or remote computing system, the glucose level controlsystem 5802 may establish a communication channel with the computingsystem. This communication channel may be an encrypted channel. Furtherthe communication channel may be a direct end-to-end connection betweenthe glucose level control system 5802 and the computing system. Once thecommunication channel is established, the glucose level control system5802 may transmit the medicament dose control signal data or theindication of the quantity of medicament to the computing system.

Generally, the operations associated with the block 7202 may be repeatedmultiple times throughout the course of the tracking period. Forexample, in some cases, an medicament dose control system associatedwith basal medicament may be generated up to 288 times a day.Accordingly, tracking the medicament therapy may include storingmedicament does control signals and/or corresponding indications ofquantities of medicament for a plurality of autonomously determineddoses of medicament infused into the subject throughout the trackingperiod.

Generally, counter-regulatory agent therapy includes administering acounter-regulatory agent (e.g., glucagon) when there is a risk oroccurrence of hypoglycemia. Usually, the counter-regulatory agent is notsupplied on periodic or daily basis. However, it can be useful tounderstand the amount and frequency that counter-regulatory agent isadministered to the subject. For example, it may help a healthcareworker or user guide or adjust care for the subject. Further, trackingcounter-regulatory agent use may help determine a minimum quantity ofcounter-regulatory agent that should be accessible to the subject,either in a bi-hormonal pump or for use in injection therapy. The block7202 may include tracking the counter-regulatory agent administeredduring the tracking period. Tracking the counter-regulatory agenttherapy may include storing an indication of autonomously determineddoses of counter-regulatory agent delivered to the subject responsive tothe glucose level signal obtained.

At block 7204, a configuration code can be generated based on data fromthe tracked medicament therapy. The data can be based on the trackedmedicament therapy provided in block 7202. The data can be storedlocally (e.g., on the glucose level control system 5802) or remotely ona remote computing device. The configuration code can be generated bythe glucose level control system 5802. Alternatively, the configurationcode can be generated by a remote computing device provided access tothe data.

The configuration code can include one or more of a plurality of encodedGLCSP. The encoded GLCSP can be determined based on one or more dosingparameters, setting parameters, and/or control parameters.

The encoded dosing parameters can include a correction dosing parameter.The correction dosing parameter can be based on some or all of thecorrection boluses of medicament administered during the trackingperiod. For example, the correction dosing parameter can be based on amoving average of correction boluses administered to the subject. Thecorrection dosing parameter may include determining an averagecorrection bolus provided to the subject per day over the trackingperiod. The average correction bolus may be determined by adding thetotal amount of correction doses administered each day and dividing bythe number of days in the tracking period. In some cases, one or moredays, or time periods, of the tracking period may be omitted whendetermining the average correction bolus because, for example, the oneor more days or time periods may be determined to be outliers. Theoutliers may be omitted to provide a more accurate understanding ofaverage insulin needs or consumption. While, a correction bolus is oftensupplied in response to a determination that a subject's blood glucoselevel is spiking or exceeding a threshold, and not necessarily as aregular dose of insulin, correction dosing parameters based on anaverage correction bolus can provide an initial starting point for aglucose level control system.

Alternatively, or in addition, the correction dosing parameter can bethe moving average of correction doses in combination with a rate ofchange of blood glucose from a unit of insulin provided duringcorrection therapy. The correction factor can be based on receivingglucose level data of the subject obtained during a specified timeduration; causing the ambulatory medicament pump to deliver the firstspecified doses of insulin information stored in the to the subject fora predetermined time duration; determining from the glucose level data adecrease in the glucose level of the subject during the specified timeduration; calculating an effective correction factor for the subjectbased on the decrease in the glucose level and an amount of the firstspecified insulin correction bolus; and adjusting the first specifieddoses of insulin in consideration of the effective correction factor.

The encoded dosing parameters can include a food intake dosingparameter. The food intake dosing parameter can be based on some or allof the food intake boluses of medicament provided during the trackingperiod. Generating the food intake dosing parameter may includedetermining, for each period of food intake of a plurality of foodintake times per day (e.g., snacks or mealtimes), an average food intakebolus of insulin provided to the subject over the tracking period. Insome cases, the average food intake bolus may be determined forparticular meals (e.g., breakfast, lunch, and dinner), while otherperiods of food intake (e.g., snacks or teatime) may be omitted orignored. Further, the average food intake boluses may be associated withparticular meal sizes as identified by a user. For example, the glucoselevel control system 5802 may determine an average mealtime bolus for asmall and a large meal, or for a small, a medium, and a large meal. Theaverage food intake bolus may be determined by averaging an amount ofinsulin the glucose level control system 5802 determines should beadministered to the subject using a control algorithm of the glucoselevel control system 5802 for each mealtime and identified meal size. Afood intake bolus size used to generate the food intake boluses ofmedicament can be adapted over time based at least in part on one ormore glucose level signals received from a glucose sensor configured todetermine glucose levels in the subject. The encoded dosing parameterscan be determined based on food intake parameters of the subject. Thefood intake dosing parameter can include a plurality of calculated foodintake dose amounts. One calculated food intake dose amount cancorrespond to a segment of a day different from at least one othercalculated food intake dose amount of the plurality of calculated foodintake dose amounts.

The encoded dosing parameters can include a basal dosing parameter. Thebasal dosing parameter can be based on some or all of the basal doses ofmedicament provided during the tracking period. The basal dosingparameter can be based the moving average of the nominal basal dosesover the tracking period. For example, the tracked medicament therapymay include determining a moving average of the past 7 days of nominalbasal doses during each dosing interval. The basal dosing parameter mayinclude determining a number of long acting medicament units based atleast in part on an average total basal medicament provided to thesubject per day over the tracking period. The averaged total basalmedicament provided per day may be included in the basal dosingparameter as a single dose of long acting medicament that is configuredto help maintain the basal medicament level of the subject throughoutthe day.

Alternatively, or in addition, the basal dosing parameter may be basedon a rate of basal medicament provided within one or more sub-periods ofthe tracking period. In some cases, each day of the tracking period maybe divided into a plurality of sub-periods. For example, each day of thetracking period may be divided into two, three, four, or more timeperiods, or equal or different length. In some such cases, basal dosingparameter may include determining an hourly basal rate for eachsub-period of the plurality of sub-periods. This hourly basal rate maybe determined by averaging the corresponding sub-periods for each day ofthe tracking period. The basal rate may be determined on an hourly rateor based on any other time period.

The encoded dosing parameters can include on one or more demographicparameters. The demographic parameters may include characteristicsshared among large portions of a population (e.g., weight, gender, age,etc.) as well as characteristics that may be unique or specific to thesubject, or shared among few people (e.g., characteristics related togenetics).

The encoded dosing parameters can be determined based on a carbohydrateratio. The carbohydrate ratio can be calculated based on medicamentsprovided during the tracking period.

The encoded dosing parameters can be determined based on a glucagon rateinformation. A glucagon dosing parameter can be based on at least someglucagon doses administered during the tracking period.

The encoded dosing parameters can be determined based on one or morephysiological parameters can include using one or more subject sensors,such as a CGM sensor, weight, heart rate, etc.

The configuration code can be further based on a control parameter. Theconfiguration code can include the encoded control parameter. Thecontrol parameter can be based on execution of a control algorithmduring the tracking period. In some examples, the time of delivery anddose of the plurality of therapies may be based at least in part on theglucose level signal and the first value of a control parameter of thecontrol algorithm used by the glucose level control system 5802. Thecontrol parameter may include any control parameter that affectsoperation of the glucose level control system 5802 and/or performance ofa control algorithm of the glucose level control system 5802. Forexample, the control parameter can be Tmax, T_(1/2), speed of deliveryof a medicament dose, a setpoint for the glucose level, a blood glucoserange, a threshold value of blood glucose level (e.g., a maximum orminimum value) and the like. The control algorithm may include anycontrol algorithm and/or PK model used to determine a dose of medicament(e.g., insulin) to administer to the subject. In other words, thecontroller 5810 or the separate processor 5820 may use the controlalgorithm to generate a dose control signal based at least in part on avalue of the control parameter to cause the delivery device(s) 5806 toadminister a dose of insulin or other medicament.

The configuration code can be further based on a setting parameter. Theconfiguration code can include the encoded setting parameter. Thesetting parameter may be used by the glucose level control system inidentifying the subject and/or configuring the glucose level controlsystem during the tracking period. The setting parameters can include asubject identifier. The setting parameter can be used by the glucoselevel control system in identifying a subject during the trackingperiod. The subject identifier can include the name or personalidentification number of the subject. The setting parameters can includea user identifier and/or a user associated with the subject. Thecustomer identification can include information regarding ownership,safe-access level settings or rights, or other customer relatedinformation. The setting parameters can include information foridentifying the medicament pump, such as serial identificationinformation. The setting parameters can include medicament pumpsettings. The setting parameters can include operating systeminformation, such as the version number, update date, etc. The settingparameters can include alert settings (e.g., for the ambulatory pump),such as delivery preferences for sending the alert to the user,outputting an alert on a display, transmitting an alert to an account ordevice of the user, generating an audio alert or a visual alert, or anyother type of alert. The setting parameters can include user interfacesettings such as menu options, passwords or related settings. Thesetting parameter may contain a plurality of pump parameters thatreproduce part of or all of a “state” or comprehensive pumpconfiguration or glucose level control system. In some cases, theconfiguration code may be used to refine pump settings for a replacementglucose level control system to be used by the subject. In other cases,the replacement glucose level control system may be manually configuredbased on the configuration code or the configuration data encoded in theconfiguration code.

The configuration code generated by the process 7200 can be a string ofcharacters (e.g., alphanumeric), link or reference, QR code, machinereadable code, or other type of code. The configuration code can be apredetermined length (e.g., 16 bytes or 16 characters or more).Generating or receiving the configuration code at block 7204 can includegenerating a checksum for checking an error in a generation of theconfiguration code. The configuration code can include a time-basedparameter. The time-based parameter can include a timestamp indicatingan age of the configuration code, age of data derived during thetracking period, or an expiration date of the configuration code.

The configuration code can include a subject identification. The subjectidentification can include the name or personal identification number ofthe subject. The configuration code may be based on or include a uniquepersonal identification of the subject, making each configuration codeunique to a specific subject. The configuration code may be single-use(e.g., usable only once for a particular glucose level control system).Re-use of the same code my trigger a rejection of the configurationcode. The configuration code may be a personal passcode for a newglucose level control system. The glucose level control system mayrequire a confirmation code for initial use.

Generating the configuration code at block 7204 can include a safetycheck, such as an information checksum. The checksum and verify whetherthe pump parameters are within threshold parameters (e.g., based on thetracked medicament therapy administered to the subject). The thresholdparameters can be preset for the subject (e.g., based on weight). Thethreshold parameters can be determined based on history of therapystored in the cloud-based server and associated with the subjectidentifier. Generating the configuration code at block 7204 can includea step of communicating with a healthcare provider via a data interfaceto enter parameters, verify parameters, safety check, generate anencrypted source code, verify subject, or other verifications.

At block 7206, the glucose level control system 5802 or remote computingdevice outputs the configuration code. Outputting (or generating) theconfiguration code may include encrypting the configuration code andoutputting the encrypted configuration code. Outputting theconfiguration code may include displaying the configuration code on adisplay or user interface (e.g., a QR code or alphanumeric code).Outputting the configuration code may include may be in response to arequest by a user of the user interface. Outputting the configurationcode may include may be in response to an automated backup protocol oran input from a remote source (e.g., a command indicating that a newglucose level control system is being implemented). The user interface5824 can be implemented in the ambulatory medicament pump in the form ofa graphical user-interface configured to output the configuration codeand/or backup therapy protocol. In some cases, the configuration codemay be stored at the glucose level control system 5802 and may beaccessed in response to a user interaction with a user interface of theglucose level control system 5802. Outputting the configuration code maybe part of or used in conjunction with display of a backup therapyprotocol. Alternatively, or in addition, outputting the configurationcode may include transmitting the configuration code to a computingdevice of a user for display and/or storage.

Outputting the configuration code can include transmitting theconfiguration code to a second glucose level control system or to anelectronic device in communication with the glucose level control system(e.g., wired or wirelessly through networked communication). The secondglucose lever control system can generate a checksum to check for errorsin the transmission of the configuration code.

The glucose level control system 5802 can output a link to theconfiguration code and/or the configuration data encoded in thegenerated configuration code stored at a remote computing location. Whencustomizing another glucose level control system (e.g., initializing thesystem) the link can be input through the user interface manually or byan automatic process, as described further below. The glucose levelcontrol system can use the link to identify, access, and download theencoded configuration data and/or the configuration code. In certainimplementations, the configuration code can include the link to theremote computing location. When initializing another glucose levelcontrol system the configuration code can be input and the glucose levelcontrol system can use the linked configuration code to access anddownload the configuration data.

The configuration code may also be updated over time as additionalmedicament therapy data is obtained. The configuration code may also beupdated by repeating blocks 7202 and 7204 continuously or at intervals(e.g., in response to a request) as additional medicament therapy datais obtained. In one example, the configuration code can be updated basedon a generation request from a user (e.g., through the user interface).In another example, the configuration code can be automaticallycalculated and/or output in response to startup or shutdown of theglucose level control system 5802.

Similar to the backup therapy protocol discussed above, someimplementations of the configuration code generated can be configured toproduce a “conservative” approach to therapy (e.g., at least duringinitial stages of therapy followed by use of the adaptive controlalgorithm).

FIG. 73 presents a flowchart of a process 7300 for receiving aconfiguration code and setting parameters on a glucose level controlsystem based on the configuration code. A configuration code, as outputby the configuration code generation process 7200, can be used inconjunction with another glucose level control system. The configurationcode customizes therapy (e.g., initial therapy) provided by the secondglucose level control system. The original glucose level control systemcan also include the capacity to receive a configuration code or utilizethe generated configuration code.

At block 7302, the glucose level control system 5802 receives aconfiguration code. The configuration code can be entered at the userinterface. The user interface can include a prompt on first-time startupto enter a configuration code. The user interface can alternativelyprovide a menu location for entering the configuration code.Alternatively, the glucose level control system 5802 can be shippedincluding the configuration code pre-loaded. In another alternative, theconfiguration code can be entered through a networked connection with anelectronic device.

Alternatively, the second configuration code is received from anelectronic computing device in communication with the glucose levelcontrol system (e.g., automatically). The configuration code can bereceived from the electronic computing device in response to a requestfrom the glucose level control system.

At block 7304, the glucose level control system 5802 identifies acontrol parameter based on the received configuration code. The controlparameter can be a parameter that influences a control algorithm thatgenerates control signals for controlling the administration ofmedicament to the subject. Control parameters can include weight, thecorrection factor, the carb ratio, the basal rate, food intake bolussize, etc. Identifying the control parameter can include decrypting theencoded dosing parameter of the configuration code and/or using a lookuptable based on the configuration code. In certain implementations, theconfiguration code can identify multiple control parameters.

At block 7306, the glucose level control system 5802 sets an identifiedcontrol parameter to a value based on the received configuration code.The configuration code can also include a value (or range) for thecontrol parameter. Identifying the value of the control parameter caninclude decrypting the encoded dosing parameter of the configurationcode. In certain implementations, the value comprises an initial valuefor the control parameter. The control parameter can be adapted overtime based at least in part on the medicament therapy administered overthe tracking period. Where multiple control parameters are identified,each can include a value (or range).

The glucose level control system 5802 can verify a checksum of theconfiguration code. Setting the control parameter to the value can beperformed in response to successfully verifying the checksum of theconfiguration code. The glucose level control system 5802 can alsoinclude a check to verify that the glucose level control system 5802 isthe intended recipient of the configuration code. The glucose levelcontrol system 5802 can determine a first reference code associated withthe configuration code and determine a second reference code associatedwith the glucose level control system. If the first reference codematches the second reference code, setting the control parameter to thevalue can be performed. The first reference code and the secondreference code can correspond to one or more versions of controlsoftware capable of being executed by the glucose level control system5802. Where the first reference code and the second reference code donot correspond, the value of the control parameter can remain at aninitial or default level. Alternatively, where the first reference codeand the second reference code do not correspond, the value of thecontrol parameter can be set based at least in part on a modifiedversion of the second configuration code. For example, the value can bemodified to stay within a safe range (e.g., min and/or max) for thecontrol parameter.

The glucose level control system 5802 can determine whether the value ofthe identified control parameter is safe for the subject by determiningwhether the value is within a threshold range (e.g., safety maximumand/or minimum, as described above) or a historical value for thecontrol parameter. The historical value can include an average valueover a particular time period or a most recent value of the controlparameter. The historical value can be obtained based on a history ofmedicament therapy stored at the glucose level control system. Thehistorical value can be obtained based on a history of medicamenttherapy stored at an electronic device in communication with the glucoselevel control system.

At block 7308, the glucose level control system 5802 can provide glucoselevel therapy based on the value set on the identified controlparameter. After initializing the control parameter, the controlalgorithm can provide tracked medicament therapy to the subject. Theinitial period may be 1 day, 1 hour, or other time frame. Any necessaryupdates to the control parameter can be based on the adaptive controlalgorithm used by the one or more controllers described above and whichmay adapt over time to control the subject's glucose levels.

FIG. 74 presents a flowchart of a process 7400 for receiving a link toaccess a configuration code (or a configuration code comprising a linkor reference) stored in a remote computing system and setting parameterson a glucose level control system based on the configuration dataretrieved from the remote computing system. A configuration code orconfiguration data based on the configuration code (e.g., as output bythe configuration code generation process 7200 to a remote computinglocation) can be used to customize therapy provided with another glucoselevel control system. The configuration code customizes at least initialtherapy provided by the second glucose level control system.

At block 7402, the glucose level control system 5802 receives a link orreference to a remote computing location. The remote computing locationcan include configuration data including the dosing parameters and/orthe configuration code. The link can be manually or automaticallyentered through a user interface, as described above.

At block 7404, the glucose level control system 5802 identifies areference to a remote computing system based on the link. The remotecomputing system can be accessed through a networked connection. Theremote computing system can include the stored configuration code and/orconfiguration data, such as the dosing parameters.

At block 7406, the glucose level control system 5802 downloads theconfiguration data from the remote computing system. The configurationdata can be downloaded through a networked connection.

At block 7408, the glucose level control system 5802 identifies acontrol parameter based on the downloaded configuration data.Identifying the value of the control parameter can include decryptingthe encoded dosing parameter of the configuration code. Alternatively,the glucose level control system 5802 identifies the control parameterat the remote storage location and downloads the identified controlparameter. In certain implementations, the configuration code canidentify multiple control parameters.

At block 7410, the glucose level control system 5802 sets the identifiedcontrol parameter to a value based on the downloaded configuration data.Setting the identified control parameter to a value can include one ormore safety checksums, such as those described above in blocks 7306 and7204. In certain implementations, the value comprises an initial valuefor the control parameter. The control parameter can be adapted overtime based at least in part on the medicament therapy administered overthe tracking period. Where multiple control parameters are identified,each can include a value (or range).

At block 7412, the glucose level control system 5802 can provide glucoselevel therapy based on the value set on the identified controlparameter. After initializing the control parameter, the controlalgorithm can provide tracked medicament therapy to the subject. Theinitial period may be 1 day, 1 hour, or other time frame. Any necessaryupdates to the control parameter can be based on the adaptive controlalgorithm used by the one or more controllers described above and whichmay adapt over time to control the subject's glucose levels.

Modular Blood Glucose Control Systems

Blood glucose control therapy generally requires the coordination ofmany elements within a system. For example, a blood glucose controltherapy system can broadly include a medicament delivery system (e.g., amedicament pump, a patch pump, a medicament pen, a hospital infusionpump) and a glucose sensor (e.g., a continuous glucose monitor (CGM)),and each of those elements may include one or more sub-elements. Inorder for the blood glucose control therapy to be properly dosed anddelivered, the various elements must be able to properly communicatewith one another. For example, the glucose sensor and the medicamentdelivery system must be able to communicate with one another. This needto communicate often demands that the medicament delivery system and theglucose sensor be specially configured to communicate with each other.Thus, modern systems do not generally allow for a medicament deliverysystem to communicate with a plurality of glucose sensors, or for aglucose sensor to communicate with a plurality of medicament deliverysystems. However, systems and methods described herein help solve thisdeficiency.

Although any medicament delivery system may be used in the systems andmethods described herein, for convenience reference will be made to amedicament pump below. A modular blood glucose control therapy systemcan provide interoperability between a medicament pump and a pluralityof different glucose sensors (e.g., glucose sensors made by a pluralityof sensor manufacturers), and/or interoperability between a glucosesensor and a plurality of different medicament pumps (e.g., medicamentpumps made by a plurality of pump manufacturers).

The modular blood glucose control therapy system can include a datainterface that is configured to transmit a dose control signal to a pumpcontroller and to receive a glucose level signal from a glucose sensor.The glucose level signal received from the glucose sensor may includeencoded data that can be read only by one or more medicament pumps. Themodular blood glucose control therapy system can be configured to decodethe encoded data. The glucose level signal may include, for example,first encoded data corresponding to a glucose level of the subjectand/or second encoded data corresponding to an indication of a glucosetrend. The glucose trend may indicate one or more signals, such as apredicted change in the glucose level of a subject.

One way to allow interoperability among different medicament pumps anddifferent glucose sensors is to include a plurality of encoding profilesand/or decoding profiles. The modular blood glucose control therapysystem can therefore include a plurality of dose control signal encodingprofiles and/or glucose level signal decoding profiles. Each of theplurality of dose control signal encoding profiles may correspond to atleast one of a plurality of pump controllers of associated medicamentpumps. Each dose control signal encoding profile can be configured toencode a dose control signal for transmission to the corresponding pumpcontroller. The modular blood glucose control therapy system can beconfigured to select the dose control signal encoding profile thatcorresponds to the pump controller operatively coupled to the subject.If a subject changes medicament pumps, the modular blood glucose controltherapy system can modify which dose control signal encoding profile(s)it uses to communicate with the medicament pump (if necessary),according to some embodiments. Additionally or alternatively, each ofthe plurality of glucose level signal decoding profiles can correspondto at least one of a plurality of glucose sensors, wherein each glucoselevel signal decoding profile is configured to decode at least the firstencoded data and the second encoded data of the glucose level signal,and wherein the selected glucose level signal decoding profilecorresponds to the glucose sensor operatively coupled to the subject.

The modular blood glucose control therapy system may be self-containedwithin a small modular component, such as within a chip. The system cancomprise a system on a module (SOM), which can allow the module to bedisposed within a number of medical devices, such as a medicament pump(e.g., an ambulatory medicament pump), a glucose sensor (e.g., acontinuous glucose monitor (CGM)), or other medical device. The modularblood glucose control therapy system can be able to include a datainterface to communicate with other electronic devices, such as a remotenetwork (e.g., cloud, server), a medicament pump, a glucose sensor,and/or a computing device (e.g., a laptop, cell phone, smartphone,Personal Diabetes Manager (PDM), tablet, wearable electronic device,etc.). The data interface can include a wired data interface and/or awireless data interface. The data interface may refer to a plurality ofdata interfaces. Each data interface of the plurality of data interfacesmay be configured to communicate with a different electronic device.

The modular blood glucose control therapy system can include one or morealgorithms stored thereon, such as the control algorithm describedabove. The system can output a dosing recommendation to a pumpcontroller via a wired and/or wireless data interface. The system canintegrate cellular wireless and/or GPS radio module(s) as well. Thedosing recommendation can include a command or instruction to the pumpcontroller. Additionally or alternatively the recommendation may includea displayed recommendation but no command for some reason (e.g., thatthe medicament pump or a component thereof), and feedback can beaccepted (e.g., in case the user performs a manual injection)

The system can include one or more computing components, including amicroprocessor, a Bluetooth Low Energy (BLE) wireless modem, a clock,and/or non-volatile memory to independently operate and maintain awireless connection and/or calculate dosing results. As described inmore detail below, the system can save and restore algorithm states dataand other data on the module. Additionally or alternatively, the systemcan receive remote software upgrade services and provide them to atarget pump controller or other associated medical device. Because ofthe benefits of the system (e.g., the small form factor), the system canbe part of a digital infrastructure that provides interactivity amongmultiple electronic devices, such as a mobile device, wearable device(e.g., smart watch), cloud network, and/or third-party services. Thesystem may include a hardware and/or software validation package thatsatisfies public standards, such as, for example, FCC, EMC/EMI, IEC62304, or other validation standard. In some examples, the system can becoupled directly to an infusion pump, such as a pump in a hospital room.

The modular blood glucose control therapy system may receive one or moreinputs from a user and/or from another device. For example, the systemmay receive glucose sensor pairing information. The pairing informationcan include credentials that allow it to pair with the glucose sensor,which may be remote from the modular system. As described below, themodular system can include pairing information for a plurality ofglucose sensors. The various credentials (e.g., encoding and/or decodingprofiles) may be stored on the modular system. Thus, in someembodiments, the modular system can communicate with a plurality ofmodels and/or glucose sensors from a plurality of manufacturers.

The modular system can receive various details related to a subjectreceiving therapy. For example, the system may receive a body weightand/or blood glucose control parameters from a remote device and/or froma directly coupled medical device. In some embodiments, the modularsystem can receive meal announcement requests and/or a pump status.Additional details are provided below.

The modular blood glucose control therapy system can receive indicationsof the status of the pump controller. For example, the modular systemcan receive an indication that the pump controller is available and/orthat it is not available for delivery of therapy. In some embodiments,the modular system may receive a delivery report. The delivery reportmay indicate how much therapy was delivered since a previous time (e.g.,since a most recent status request). The delivery report can include arecommendation for future therapy. The recommendation may include acommand to deliver the recommended therapy.

As described in more detail below, the modular system may have theability to receive pass-through data and route that data to a targetdevice. Pass-through data may include data that is unrelated to a dosecontrol signal and/or not used in a calculation of a dose controlsignal. The pass-through data may include an alert related to athird-party system. For example, the pass-through data may include anindication that a pump cartridge has a volume of medicament below athreshold volume or that a supply of medicament is below a thresholdsupply. The indication may include a charge level associated with abattery of the ambulatory medicament pump and/or that an associatedglucose sensor has exceeded a threshold performance period. In someembodiments, the data may include an indication that a new pumpcartridge has been installed in the ambulatory medicament pump. In someembodiments, the modular system can receive information (e.g., thepass-through data) from a third-party pump element for display on a userinterface. The user interface may include a personal computing device,such as a smartphone, a PDM, a tablet, and/or another display device.

The modular system can receive software upgrades for the modular systemvia a data interface (e.g., a wireless data interface). The datainterface can include a Bluetooth module (e.g., BLE) and/or a wirelessmodem (e.g., an LTE-M). in some embodiments, the modular system receivesan indication from the medicament pump which medicament(s) (e.g., U100,U200, glucagon, etc.) will be delivered by the pump. The system mayreceive an indication from the medicament pump when delivered insulinreaches a point of maximum concentration within the blood of the subject(e.g., T_(max)). The T_(max) value may be updated by the medicament pumpat regular or periodic intervals. The system may receive a target bloodglucose level, a setpoint level, the T_(max), and/or other blood glucosecontrol parameters.

The modular system may receive other signals. For example, the modularsystem can receive instructions to control the medicament pump. Theseinstructions can include a pause in insulin, a duration of such a pause,a resume signal, an updated rate of insulin delivery (e.g., increase,decrease), and/or other instructions.

The modular blood glucose control therapy system may be able to provideone or more of a variety of outputs. These outputs may be to anassociated medicament pump in some embodiments. Additionally oralternatively, the outputs may be to a glucose sensor and/or to anotherelement within a blood glucose control therapy system. The system mayoutput a dose control signal. The dose control signal can includewhether insulin only should be delivered to the subject or whetheradditional therapy should be provided (e.g., bihoromonal therapy,insulin and glucagon, etc.). The system may output a total number ofunits to be delivered of each therapy and/or a speed at which thattherapy is to be delivered. The system can encode the instructions to bereadable by one or more of a plurality of pump controllers and/orglucose sensors. As discussed below, the encoding profiles for each ofthe plurality of pump controllers and/or glucose sensors may be storedwithin the modular blood glucose control therapy system.

In some embodiments, the system can output to a medicament pump a statusand/or reading from an associated glucose sensor. Additionally oralternatively, the system may output a status of an algorithm, such asthe control algorithm described herein. For example, the system mayalert a user that the algorithm has encountered a problem.

The modular blood glucose control therapy system can output a warning,an error, an alarm, or other indication configured to draw urgentattention by a user. The system can output a basal rate, one or moreblood glucose control parameters, an amount of insulin on board, a mealannouncement status or availability, and/or a command to pause and/orresume delivery of therapy. Additionally or alternatively, as notedabove, the modular system can route received pass-through data to one ormore target devices. The pass-through data may be received from anydevice, such as a pump controller, a glucose sensor, and/or from aseparate electronic device (e.g., a user device). In some embodiments,the system can receive encoded glucose sensor signal comprising secondpass-through data and/or encoded source device signal comprising thirdpass-through data. The second and/or third pass-through data can berouted to a corresponding second and/or third target electronic device.This data may be received and/or transmitted wirelessly, such as througha BLE and/or LTE-M. Additional details are provided below with referenceto individual figures. The blood glucose control parameters may bedetermined at least in part on a glycemic response of the subject over atherapy interval. The therapy interval may be on the order of hours,days, weeks, months, or years. In some embodiments, the therapy intervalis between about 10 seconds and 10 minutes. Additionally oralternatively, the blood glucose control parameters may be determined atleast in part based on glycemic response of the subject to a medicamentbolus delivered by the medicament pump.

The blood glucose control system may determine the blood glucose controlparameters may be determined by learning the blood glucose controlparameters during online operation of an automated blood glucose controlsystem. For example, the modular system may generate the blood glucosecontrol parameters by calculating a size of a correction bolus ofinsulin of the regular correction boluses at a time of receiving anisolated glucose measurement from the glucose sensor. Additionally oralternatively, the system may generate the blood glucose controlparameters by calculating a size of a meal bolus of insulin. The bloodglucose control parameters may be determined by use of the controlalgorithm described above.

FIG. 75 shows a blood glucose control system 7506 disposed within amedicament pump 7500 operatively coupled to the subject. The medicamentpump 7500 includes a pump mechanism 7502, a pump controller 7504, andthe blood glucose control system 7506. The blood glucose control system7506 includes a data interface 7508. As mentioned above, the datainterface 7508 may include a wireless and/or wired data interface. Theblood glucose control system 7506 an include a short-range wireless datainterface.

The medicament pump 7500 may be any medicament pump described herein,such as the pump 100 and/or pump 212. The pump controller 7504 isconfigured to direct medicament from a medicament reservoir to thesubject using the pump mechanism 7502.

The data interface 7508 may be in communication (e.g., wired, wireless)with one or more of a glucose sensor 7510 (e.g., via a glucose sensorconnection 7516), with a network 7512 (e.g., via a network connection7518), and/or a user device connection 7520 (e.g., via a user deviceconnection 7520). Each of the connections 7516, 7518, 7520 may beone-way or two-way. The data interface 7508 may also be in communicationwith other elements of the medicament pump 7500, such as the pumpmechanism 7502 and/or the pump controller 7504. The communication withthe other elements of the medicament pump 7500 may be via a wiredconnection.

The data interface 7508 may be configured to interface with a pluralityof glucose sensors. For example, the blood glucose control system 7506may store a plurality of decoding profiles, such as glucose level signaldecoding profiles that are configured to correspond to one or moreglucose sensors. In some examples, the blood glucose control system 7506can select a glucose level signal decoding profile from a plurality ofglucose level signal decoding profiles. Each glucose level signaldecoding profile is configured to decode encoded data of a glucose levelsignal. The selected glucose level signal decoding profile cancorrespond to the glucose sensor 7510 that is operatively coupled to thesubject.

The network 7512 may include any wired network, wireless network, orcombination thereof. For example, the network 7512 may be a personalarea network, local area network, wide area network, over-the-airbroadcast network (e.g., for radio or television), cable network,satellite network, cellular telephone network, or combination thereof.As a further example, the network 7512 may be a publicly accessiblenetwork of linked networks, possibly operated by various distinctparties, such as the Internet. In some implementations, the network 7512may be a private or semi-private network, such as a corporate oruniversity intranet. The network 7512 may include one or more wirelessnetworks, such as a Global System for Mobile Communications (GSM)network, a Code Division Multiple Access (CDMA) network, a Long TermEvolution (LTE) network, or any other type of wireless network. Thenetwork 7512 can use protocols and components for communicating via theInternet or any of the other aforementioned types of networks. Forexample, the protocols used by the network 7512 may include HypertextTransfer Protocol (HTTP), HTTP Secure (HTTPS), Message Queue TelemetryTransport (MQTT), Constrained Application Protocol (CoAP), and the like.Protocols and components for communicating via the Internet or any ofthe other aforementioned types of communication networks are well knownto those skilled in the art and, thus, are not described in more detailherein. The network 7512 may comprise the “cloud.” The network 7512 mayinclude a remote computing environment.

Various example user devices 7514 are shown in FIG. 75, including adesktop computer, a laptop, and a mobile phone, each provided by way ofillustration. In general, the user devices 7514 can be any computingdevice such as a desktop, laptop or tablet computer, personal computer,tablet computer, wearable computer, server, personal digital assistant(PDA), PDM, hybrid PDA/mobile phone, mobile phone, smartphone, set topbox, voice command device, digital media player, and the like. A userdevice 7514 may execute an application (e.g., a browser, a stand-aloneapplication) that allows a user to access and interact with interactivegraphical user interfaces as described herein.

The glucose sensor 7510 may be configured to transmit data to themedicament pump 7500 via the data interface 7508. The data may beencoded based on the make of the glucose sensor 7510 and/or based onanother characteristic. The encoded data may comprise a glucose levelsignal. The glucose level signal can include first encoded data and/orsecond encoded data. The first encoded data may correspond to a glucoselevel of the subject, and the second encoded data may include anindication of a glucose trend. The glucose trend indicates at least apredicted change in the glucose level of the subject.

The blood glucose control system 7506 may include a processor that isconfigured to execute instructions. The blood glucose control system7506 can receive, via the data interface 7508, a glucose level signalfrom the glucose sensor 7510. The glucose sensor 7510 may be operativelycoupled to the subject. The blood glucose control system 7506 can decodethe first and second encoded data of the glucose level signal to obtainthe glucose level of the subject and the indication of the glucosetrend. Based on the decoded data, the blood glucose control system 7506can calculate a dose control signal using a control algorithm that isconfigured to calculate regular correction boluses of glucose controlagent in response to at least the glucose level of the subject. Thecontrol algorithm may include features described elsewhere herein.

In some embodiments, the blood glucose control system 7506 can beconfigured to communicate with one or more of a plurality of pumpcontrollers. In such embodiments, the blood glucose control system 7506may be configured to select a dose control signal encoding profile froma plurality of dose control signal encoding profiles. Each of theplurality of dose control signal encoding profiles may correspond to atleast one of a plurality of pump controllers, including the pumpcontroller 7504. The selected dose control signal encoding profilecorresponds to the pump controller operatively coupled to the subject.

The blood glucose control system 7506 may encode the received dosecontrol signal using the selected dose control signal encoding profilesuch that the pump controller 7504 can read the dose control signal.Once encoded, the dose control signal may be transmitted to the pumpcontroller 7504 of the medicament pump 7500. The dose control signal maybe configured to command the medicament pump 7500 to administer glucosecontrol therapy via infusion of the glucose control agent into thesubject. The glucose control agent may include insulin, glucagon, and/orother agent disclosed herein.

In some embodiments, the blood glucose control system 7506 can transmitvia the data interface 7508 data to a graphical user interface. Forexample, the blood glucose control system 7506 may transmit one or moreof the glucose level of the subject and/or the indication of the glucosetrend to the graphical user interface. Additionally or alternatively,the glucose level may be transmitted to a remote device, such as a userdevice 7514 and/or the network 7512, via a corresponding connection7518, 7520.

As noted above, the blood glucose control system 7506 can output one ormore blood glucose control parameters to the one or more devices, suchas the user device 7514 and/or the network 7512. As described above,example blood glucose control parameters may include: an insulin decayrate constant associated with a decay rate of insulin at a subcutaneousdepot of the subject and/or a clearance time associated with an estimateof an amount of time for a bolus of insulin to be utilized by thesubject. The blood glucose control parameters may additionally oralternatively include an insulin rise rate constant associated with arise rate of insulin in blood of the subject after a bolus of insulinand/or a value (e.g., half-life value) associated with when aconcentration of insulin in blood plasma of the subject reaches athreshold (e.g., half of a maximum) concentration in the blood plasma.In some embodiments, the blood glucose control parameters may include asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament. Other parameters may be included,such as those with reference to the control algorithm above.

The blood glucose control system 7506 can receive various data from theglucose sensor 7510 and/or from the user device 7514. For example, theblood glucose control system 7506 may receive, via the data interface7508, an amount of insulin on board and/or a value used in apharmacokinetic (PK) model of the control algorithm described above. Theblood glucose control system 7506 may be configured to execute thecontrol algorithm.

In some embodiments, the blood glucose control system 7506 cancommunicate with one or more of a plurality of glucose sensors,including the glucose sensor 7510. Each glucose sensor can transmitglucose level signals in an encoded form (e.g., format), and the bloodglucose control system 7506 can have a corresponding glucose levelsignal decoding profile for each glucose sensor. The blood glucosecontrol system 7506 may have each glucose level signal decoding profilefor each glucose sensor stored thereon. In some embodiments, the bloodglucose control system 7506 can select a glucose level signal decodingprofile from the plurality of glucose level signal decoding profiles.Each glucose level signal decoding profile may be configured to decodeat least a glucose level of the subject and an indication of a glucosetrend, which may indicate at least a predicted change in the glucoselevel of the subject. The selected glucose level signal decoding profilecan correspond to the glucose sensor 7510 that is operatively coupled tothe subject. Using the selected glucose level signal decoding profile,the blood glucose control system 7506 can decode the glucose level ofthe subject and/or the indication of the glucose trend of the glucoselevel signal.

Another benefit of some embodiments of the blood glucose control system7506 is it can be configured to store historical data thereon. In thisway, the data may not be lost and can be preserved for a futuremedicament pump 7500. For example, the medicament pump 7500 may bedisposed of, and a user or other individual may be interested in thestored historical data on the blood glucose control system 7506. Suchhistorical data can include a therapy delivery history, one or moreblood glucose control parameters, and/or other data that may be storedover time on the blood glucose control system 7506. The blood glucosecontrol system 7506 can calculate a dose control signal for use in themedicament pump 7500 in some embodiments. Over time, the generated dosecontrol signal(s) may be stored on the blood glucose control system7506.

Once stored, the blood glucose control system 7506 may be configured totransmit the stored data to a remote electronic device (e.g., theglucose sensor 7510, the network 7512, the user device 7514) once atriggering condition is satisfied. The triggering condition can includeone or more of a variety of triggering conditions. These conditions mayindicate or reflect a change that is occurring on the medicament pump7500 and/or on the blood glucose control system 7506. For example, thetriggering condition may include a sensory alarm that alerts a user thatthe blood glucose control parameters are ready for transmission. Thesensory alarm may prompt a user to cause the blood glucose controlsystem 7506 to transmit the data to the remote electronic device. Thetriggering condition may include a determination that a level ofmedicament in an associated medicament reservoir is below a thresholdlevel. The medicament reservoir may be included in the medicament pump7500 (not shown in FIG. 75). Additionally or alternatively, thetriggering condition can include a signal received from the remoteelectronic device requesting transmission of the blood glucose controlparameters. In some embodiments, the triggering condition includes auser-generated indication to replace the disposable ambulatorymedicament pump. Other conditions are possible and these are listed byway of illustration only.

In embodiments where the triggering condition includes a sensory alarm,the sensory alarm may be configured to regularly and/or periodicallyalert the user and/or subject until the blood glucose control parametersare transferred to the remote electronic device. For example, thesensory alarm can include a visual, audible, haptic, and/or other alarm.in some embodiments, the sensory alarm includes a beep, a tone, and/orother audible alarm. The alarm may include a vibration and/or flashinglight. The sensory alarm may be configured to be annoying to a user sothat the user is motivated to provide instructions for the blood glucosecontrol system 7506 to send the stored data to the remote electronicdevice.

In some embodiments, the blood glucose control system 7506 can receiveand route pass-through data to another device, such as a remoteelectronic device. Pass-through data can include data that is unrelatedto a glucose level signal and/or data that is not used in a calculationof a dose control signal. The pass-through data may be encoded data. Thedata may be encoded by the pump controller 7504. In some embodiments,the data is received from and encoded by the glucose sensor 7510 or someother remote device, such as the user device 7514. The blood glucosecontrol system 7506 can receive, via the blood glucose control system7506, an encoded pump controller signal (e.g., from the pump controller7504) via a digital data connection. The encoded pump controller signalcan include an encoded medicament delivery signal corresponding to anamount of medicament dosed to the subject. Additionally oralternatively, the encoded pump controller signal includes encodedpass-through data, which may include one or more signals, such asencoded pump controller alert data. The blood glucose control system7506 can also receive the glucose level signal from the glucose sensor7510. The system can additionally or alternatively receive encodedglucose sensor signal comprising second pass-through data and/or encodedsource device signal comprising third pass-through data. The secondand/or third pass-through data can be routed to a corresponding secondand/or third target electronic device

The blood glucose control system 7506 can decode the encoded medicamentdelivery signal and the encoded pass-through data to obtain the amountof medicament dosed to the subject and the data unrelated to a glucoselevel signal. Based on this decoded information, the blood glucosecontrol system 7506 can calculate (e.g., automatically) the dose controlsignal using the control algorithm configured to calculate regularcorrection boluses of glucose control agent in response to at least theglucose level of the subject and the amount of medicament dosed to thesubject. The blood glucose control system 7506 can route the dataunrelated to the glucose level signal to the target electronic device.The target electronic device may include a remote electronic device,such as the user device 7514. For example, the pass-through data may begenerated for display on the user device 7514 and/or for storage inand/or re-routing by the network 7512.

The pass-through data can include various data. For example, thepass-through data may include an indication that a pump cartridge has avolume of medicament below a threshold volume, an indication that asupply of medicament is below a threshold supply, a charge levelassociated with a battery of the ambulatory medicament pump, anindication that the glucose sensor has exceeded a threshold performanceperiod, an indication (e.g., reminder) to wirelessly couple a newglucose sensor with the ambulatory medicament pump, and/or an indicationthat a new pump cartridge has been installed in the ambulatorymedicament pump. Other pass-through data can be use, and these arelisted as examples only.

In some embodiments, the blood glucose control system 7506 can determinethat the pass-through data is unrelated to the calculation of the dosecontrol signal. Based on the determination that the pass-through data isunrelated to the calculation of the dose control signal, the bloodglucose control system 7506 route the status alert to the targetelectronic device.

FIG. 76 shows a blood glucose control system 7604 that is disposedwithin a glucose sensor system 7600. As shown, the glucose sensor system7600 includes a glucose sensor 7602 and the blood glucose control system7604. The blood glucose control system 7604 can include a data interface7606. The blood glucose control system 7604 may include functionalitydescribed above with respect to the data interface 7508. For example,the data interface 7606 may be able to communicate (e.g., wirelessly,via wired connection) with a medicament pump 7608, a network 7612,and/or a user device 7616 via respective connections 7618, 7620, 7622.The network 7612 may share one or more details with the network 7512described above. Additionally or alternatively, the user device 7616 maybe the user device 7514 described above.

As shown, the blood glucose control system 7604 can be in directconnection with other elements of the glucose sensor system 7600. Forexample, the blood glucose control system 7604 may be installed withinthe glucose sensor system 7600. The data interface 7606 can communicatewith the medicament pump 7608, such as via a wireless connection. Themedicament pump 7608 can include a pump mechanism 7610 and a pumpcontroller 7614. In some embodiments, the data interface 7606communicates with the pump controller 7614 of the medicament pump 7608.

The blood glucose control system 7604 may be configured to be operablewith one or more of a plurality of glucose sensor systems. For example,the blood glucose control system 7604 may be configured to store aplurality of pump controller decoding profiles corresponding torespective pump controllers. The blood glucose control system 7604 canbe configured to select a pump controller decoding profile from aplurality of pump controller decoding profiles.

The blood glucose control system 7604 can be configured to determine astatus of the medicament pump 7608, such as a status of the pumpcontroller 7614. The blood glucose control system 7604 can receive, viathe data interface 7606, an encoded pump status signal from the pumpcontroller 7614. The encoded pump status signal can include datacorresponding to an availability of the ambulatory medicament pump todeliver medicament to the subject. The blood glucose control system 7604can additionally or alternatively receive an encoded medicament deliverysignal from the pump controller pump controller 7614. The encodedmedicament delivery signal can include data corresponding to an amountof medicament dosed to the subject.

Each pump controller decoding profile can be configured to decode atleast an encoded pump status signal and an encoded medicament deliverysignal. The selected pump controller decoding profile can correspond tothe pump controller pump controller 7614 that is operatively coupled tothe medicament pump medicament pump 7608. Using the selected pumpcontroller decoding profile(s), the blood glucose control system 7604can decode the glucose level signal to obtain a glucose level of thesubject and an indication of a glucose trend. The blood glucose controlsystem 7604 can calculate the dose control signal using a controlalgorithm (described above) that is configured to calculate regularcorrection boluses of glucose control agent in response to at least theglucose level of the subject.

In some embodiments, in order to properly transmit the decoded data tothe pump controller 7614 (e.g., for instructions on delivering bloodglucose control therapy), the blood glucose control system 7604 canproceed to encode the data so that it can be read by the pump controller7614. Like with the pump controller decoding profiles, the blood glucosecontrol system 7604 may have stored thereon one or more of a pluralityof pump controller encoding profiles. The blood glucose control system7604 can select a pump controller encoding profile from the plurality ofpump controller encoding profiles. The selected pump controller encodingprofile can correspond to the pump controller 7614. The pump controllerencoding profile can be configured to encode at least the dose controlsignal and any other data that may be transmitted to the pump controller7614.

Based on the encoded pump status signal, The blood glucose controlsystem 7604 can determine that the medicament pump 7608 is available todeliver medicament to the subject. The blood glucose control system 7604can encode the dose control signal such that the pump controller 7614can read the dose control signal. The blood glucose control system 7604can then transmit the encoded dose control signal to the pump controller7614. The dose control signal can command the medicament pump 7608 toadminister glucose control therapy (e.g., using the pump mechanism 7610)via infusion of glucose control agent into the subject. Thus, the bloodglucose control system 7604 can be instrumental in communicating withthe medicament pump 7608 and improving interoperability between themedicament pump 7608 and the glucose sensor system 7600.

The blood glucose control system 7604 may have additional functionality,such as that described above with respect to the blood glucose controlsystem 7506 above. For example, the blood glucose control system 7604may be configured to communicate with a plurality of pump controllers,store and transmit historical data stored on the blood glucose controlsystem 7604 in response to a triggering condition, and receiving androuting pass-through data. Those details are not described again here inorder to reduce multiplicity of words.

FIG. 77 shows a flow diagram illustrating an example method 7700 thatmay be used by a blood glucose control system (e.g., the blood glucosecontrol system 7506, the blood glucose control system 7604) to calculatea dose control signal for commanding administration of glucose controltherapy to a subject. The system can receive a glucose level signal froma glucose sensor operatively coupled to a subject at block 7702. Atblock 7704 the system decodes first and second encoded data of theglucose level signal to obtain the glucose level of the subject and theindication of the glucose trend. At block 7706, the system calculate(e.g., automatically) the dose control signal using a control algorithmin response to at least the glucose level of the subject. At block 7708,the system selects a dose control signal encoding profile from aplurality of dose control signal encoding profiles. At block 7710 thesystem encodes the dose control signal using the selected dose controlsignal encoding profile such that the pump controller can read the dosecontrol signal. At block 7712, the system can transmit the encoded dosecontrol signal to the pump controller of the ambulatory medicament pump.

In some embodiments, the system can transmit, via a data interface tothe graphical user interface, one or more of the glucose level of thesubject or the indication of the glucose trend. The method 7700 mayfurther include transmitting the glucose level of the subject and/or theindication of the glucose trend to a remote electronic device.Additionally or alternatively, the system may receive, from the glucosesensor, via the data interface, blood glucose control parameters. Theblood glucose control parameters can include one or more of the bloodglucose control parameters described above. In some embodiments, thesystem can receive, via the data interface, at least one of an amount ofinsulin on board or a value used in a pharmacokinetic (PK) model of thecontrol algorithm.

In some embodiments, the method 7700 includes selecting a glucose levelsignal decoding profile from a plurality of glucose level signaldecoding profiles. Each of the plurality of glucose level signaldecoding profiles can correspond to at least one of a plurality ofglucose sensors. Each glucose level signal decoding profile may beconfigured to decode at least the first encoded data and the secondencoded data of the glucose level signal. The selected glucose levelsignal decoding profile can correspond to the glucose sensor operativelycoupled to the subject. The system may decode the first and secondencoded data of the glucose level signal using the selected glucoselevel signal decoding profile.

FIG. 78 shows a flow diagram illustrating an example method 7800 thatmay be used by a blood glucose control system (e.g., the blood glucosecontrol system 7506, the blood glucose control system 7604) to transmitblood glucose control parameters to a remote electronic device inresponse to an identification of a triggering condition. At block 7802,the system can receive, via a data interface, a glucose level signalfrom a glucose sensor operatively coupled to the subject. At block 7804,the system generates the blood glucose control parameters based ontrends in the blood glucose control therapy and the glucose level signalusing a control parameter selection process over a therapy periodspanning at least hours to days. Examples of blood glucose controlparameters are described and listed above. At block 7806, the systemgenerates, based on at least the glucose level signal and the bloodglucose control parameters, a dose control signal configured to causethe pump controller to administer the blood glucose control therapy tothe subject. At block 7808, the system identifies that at least one of aplurality of triggering conditions is satisfied. Each of the triggeringconditions can be configured to prompt transmission of the blood glucosecontrol parameters to the remote electronic device. Examples oftriggering conditions are described and listed above. At block 7810, thesystem transmits the blood glucose control parameters to the remoteelectronic device based on the satisfaction of the at least one of theplurality of triggering conditions.

In some embodiments, the system transmits, based on the satisfaction ofthe at least one of the plurality of triggering conditions, at least oneof an amount of insulin on board or a value used in a pharmacokinetic(PK) model of a control algorithm. Additionally or alternatively, thesystem generates the blood glucose control parameters further based on aglycemic response of the subject over a therapy interval. In someembodiments, the system generates the blood glucose control parametersfurther based on glycemic response of the subject to a medicament bolus.Additionally or alternatively, the system generates the blood glucosecontrol parameters by learning the blood glucose control parametersduring online operation of an automated blood glucose control system.Generating the blood glucose control parameters can include calculatinga size of a correction bolus of insulin of the regular correctionboluses at a time of receiving an isolated glucose measurement from theglucose sensor. Additionally or alternatively, generating the bloodglucose control parameters can include calculating a size of a mealbolus of insulin. In some embodiments, the system generates the bloodglucose control parameters using a control algorithm (e.g., the controlalgorithm described above).

FIG. 79 shows a flow diagram illustrating an example method 7900 thatmay be used by a blood glucose control system (e.g., the blood glucosecontrol system 7506, the blood glucose control system 7604) receive anencoded pump status signal and an encoded medicament delivery signalfrom a pump controller.

At block 7902, the system receives, via a data interface, a glucoselevel signal from the glucose sensor. At block 7904, the system decodesthe glucose level signal to obtain a glucose level of the subject and anindication of a glucose trend. At block 7906, the system generates thedose control signal using a control algorithm configured to calculateregular correction boluses of glucose control agent in response to atleast the glucose level of the subject. At block 7908, the systemreceives, via the data interface, an encoded pump status signal from thepump controller. The encoded pump status signal can include datacorresponding to an availability of the ambulatory medicament pump todeliver medicament to the subject. The system selects a pump controllerdecoding profile from a plurality of pump controller decoding profiles.Each of the plurality of pump controller decoding profiles correspondsto at least one of a plurality of pump controllers. Each pump controllerdecoding profile can be configured to decode at least the encoded pumpstatus signal and the encoded medicament delivery signal. The selectedpump controller decoding profile corresponds to the pump controlleroperatively coupled to the ambulatory medicament pump.

The system decodes the encoded pump status signal and the encodedmedicament delivery signal using the selected pump controller decodingprofile. The system can select a pump controller encoding profile from aplurality of pump controller encoding profiles. The selected pumpcontroller encoding profile corresponds to the pump controlleroperatively coupled to the ambulatory medicament pump. The pumpcontroller encoding profile is configured to encode at least the dosecontrol signal.

At block 7910, the system determines, based on the encoded pump statussignal, that the ambulatory medicament pump is available to delivermedicament to the subject and at block 7912 encodes the dose controlsignal such that the pump controller can read the dose control signal.

At block 7914, the system transmits the encoded dose control signal tothe pump controller of the ambulatory medicament pump. The dose controlsignal commands the ambulatory medicament pump to administer glucosecontrol therapy via infusion of the glucose control agent into thesubject.

FIG. 80 shows a flow diagram illustrating an example method 8000 thatmay be used by a blood glucose control system (e.g., the blood glucosecontrol system 7506, the blood glucose control system 7604) to routepass-through data unrelated to a glucose level signal to a targetelectronic device. At block 8002, the system can receive, via a datainterface, an encoded pump controller signal from the pump controllervia a digital data connection and the glucose level signal from theglucose sensor. The encoded pump controller signal can include anencoded medicament delivery signal corresponding to an amount ofmedicament dosed to the subject and pass-through data that includesencoded pump controller alert data corresponding to data unrelated to acalculation of a dose control signal.

At block 8004 the system decodes the encoded medicament delivery signaland the encoded pass-through data to obtain the amount of medicamentdosed to the subject and the data unrelated to a calculation of a dosecontrol signal. At block 8006 the system calculates the dose controlsignal using a control algorithm configured to calculate regularcorrection boluses of glucose control agent in response to at least theglucose level of the subject and the amount of medicament dosed to thesubject. At block 8008 the system routes the data unrelated to theglucose level signal to the target electronic device. The system canadditionally or alternatively receive encoded glucose sensor signalcomprising second pass-through data and/or encoded source device signalcomprising third pass-through data. The second and/or third pass-throughdata can be routed to a corresponding second and/or third targetelectronic device.

In some embodiments, the system determines that the pass-through data isunrelated to the calculation of the dose control signal. Based on thedetermination that the pass-through data is unrelated to the calculationof the dose control signal, the system can route the status alert to thetarget electronic device.

Example Embodiments

Further embodiments of glucose level control systems that can becombined with the features disclosed herein can be found in: U.S. Pat.App. No. 63/169,112 filed on Mar. 31, 2021; PCT. Pub. No. WO 2021/067856filed on Oct. 2, 2020; U.S. Pat. Pub. No. 2021/0213200 filed on Mar. 25,2021; and PCT Pub. No. WO 2021/067767 filed on Oct. 2, 2020, which areall hereby incorporated by reference in their entireties herein for allpurposes.

Some additional nonlimiting examples of embodiments discussed above areprovided below. These should not be read as limiting the breadth of thedisclosure in any way.

In a 1st example, a system for transferring historical pump data from afirst ambulatory medicament pump to a second ambulatory medicament pump,the system comprising: a data interface configured to receive thehistorical pump data from the first ambulatory medicament pump, whereinthe historical pump data comprises: first encoded data corresponding totherapy data associated with delivery of glucose control therapydelivered by the first ambulatory medicament pump to the subject; andsecond encoded data corresponding to a glucose control parameter used bythe first ambulatory medicament pump in calculating a dose controlsignal; a non-transitory memory configured to store specificcomputer-executable instructions ambulatory medicament pump; and anelectronic processor in communication with the non-transitory memory andconfigured to execute the specific computer-executable instructions toat least: receive, via the data interface, the historical pump data fromthe first ambulatory medicament pump; decode the first and secondencoded data of the historical pump data to obtain the therapy data andthe glucose control parameter; determine that at least one of aplurality of pairing conditions is satisfied to connect the datainterface to the second ambulatory medicament pump, wherein theplurality of pairing conditions comprises: a user request to pair thesystem to the second ambulatory medicament pump; a user input initiatinga replacement process for the first ambulatory medicament pump; anindication that the second ambulatory medicament pump is ready todeliver medicament to the subject; a sensory alarm configured to alert auser that the historical pump data is ready for transmission; an alertindicating a malfunction associated with the first ambulatory medicamentpump; a determination that a level of medicament in a medicamentreservoir of the first ambulatory medicament pump is below a thresholdlevel; and a signal received from a remote electronic device requestingtransmission of at least one of the therapy data associated with thedelivery of the glucose control therapy or the glucose controlparameter; transmit, via the data interface, a pairing signal to thesecond ambulatory medicament pump; receive, via the data interface, aconfirmation signal from the second ambulatory medicament pump; and inresponse to receiving the confirmation signal, transmit, via the datainterface, at least one of the therapy data associated with the deliveryof the glucose control therapy or the glucose control parameter.

In a 2nd example, the system of example 1, wherein the electronicprocessor is further configured to execute the specificcomputer-executable instructions to at least: generate, based on atleast the therapy data associated with the delivery of the glucosecontrol therapy and the glucose control parameter, a dose control signalconfigured to cause a pump controller of the first ambulatory medicamentpump to deliver the medicament to the subject.

In a 3rd example, the system of example 2, wherein generating the dosecontrol signal comprises calculating regular correction boluses ofglucose control agent in response to at least the glucose controlparameter.

In a 4th example, the system of any of examples 1-3, wherein theelectronic processor is further configured to execute the specificcomputer-executable instructions to at least: receive third and fourthencoded data, the third encoded data corresponding to a glucose level ofa subject, and the fourth encoded data corresponding to an indication ofa glucose trend, wherein the glucose trend indicates at least apredicted change in the glucose level of the subject.

In a 5th example, the system of any of examples 1-4, wherein theelectronic processor is further configured to execute the specificcomputer-executable instructions to at least: estimate a second glucosecontrol parameter based on at least one of an amount of glucose controltherapy, a time of the glucose control therapy, and/or an amount ofinsulin on board.

In a 6th example, the system of any of examples 1-5, wherein theelectronic processor is further configured to execute the specificcomputer-executable instructions to at least: receive, via the datainterface, a glucose level signal from a glucose sensor operativelycoupled to the subject; and estimate a second glucose control parameterbased on the glucose level signal received from the glucose sensor.

In a 7th example, the system of any of examples 1-6, further comprisinga graphical user interface configured to display at least the glucoselevel of the subject or the indication of the glucose trend, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: transmit to the graphical user interface, via the datainterface, one or more of the amount of the therapy data or the glucosecontrol parameter.

In an 8th example, the system of any of examples 1-7, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: transmit to the remote electronic device, one or more ofthe therapy data or the glucose control parameter.

In a 9th example, the system of example 8, wherein the remote electronicdevice comprises at least one of a mobile device or a remote computingenvironment.

In a 10th example, the system of any of examples 1-9, wherein theglucose control parameter comprises at least one of: an insulin decayrate constant associated with a decay rate of insulin at a subcutaneousdepot of the subject; a clearance time associated with an estimate of anamount of time for a bolus of insulin to be utilized by the subject; aninsulin rise rate constant associated with a rise rate of insulin inblood of the subject after a bolus of insulin; a half-life valueassociated with when a concentration of insulin in blood plasma of thesubject reaches half of a maximum concentration in the blood plasma; aweight of the subject; an age of the subject; a learned parameter;glucose level data; a model parameter associated with a pharmacokinetic(PK) model; a health state of the subject; a parameter associated withan activity level of the subject; an aspect of a diet of the subject; abasal rate of insulin delivery to the subject; a correction factor; acarbohydrate ratio associated with the subject; a glucagon controlparameter; demographic information associated with the subject; and asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament.

In a 11th example, the system of any of examples 1-10, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: receive, via the data interface, at least one of anamount of insulin on board or a value used in a pharmacokinetic (PK)model of a control algorithm.

In a 12th example, the system of any of examples 1-11, furthercomprising the first ambulatory medicament pump.

In a 13th example, the system of any of examples 1-12, wherein the datainterface comprises a short-range wireless data interface.

In a 14th example, the system of any of examples 1-13, wherein the datainterface comprises a plurality of data interfaces.

In a 15th example, the system of any of examples 1-14, wherein theinstructions, when executed by the hardware processor, are configuredto: transmit to the second ambulatory medicament pump, in response tothe confirmation signal, at least one of an amount of insulin on boardor a value used in a pharmacokinetic (PK) model of a control algorithm.

In a 16th example, the system of any of examples 1-15, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: determine that at least one of a plurality of dataretrieval conditions is satisfied to connect the data interface to thefirst ambulatory medicament pump, wherein the plurality of dataretrieval conditions comprises: an occurrence of a scheduled time; atransmission of a meal announcement; a user request to pair the systemto the first ambulatory medicament pump; the user input initiating areplacement process for the first ambulatory medicament pump; anindication that the first ambulatory pump is to be replaced; theindication that the second ambulatory medicament pump is ready todeliver medicament to the subject; the sensory alarm configured to alerta user that the historical pump data is ready for transmission; thealert indicating a malfunction associated with the first ambulatorymedicament pump; the determination that a level of medicament in amedicament reservoir of the first ambulatory medicament pump is below athreshold level; and the signal received from a remote electronic devicerequesting transmission of at least one of the therapy data or theglucose control parameter.

In a 17th example, the system of any of examples 16, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: in response to determining that the at least one of aplurality of data retrieval conditions is satisfied, receive from thefirst ambulatory medicament pump, via the data interface, at least oneof the therapy data or the glucose control parameter.

In an 18th example, the system of any of examples 1-17, wherein themalfunction associated with the first ambulatory medicament pumpcomprises at least one of an occlusion, a low battery power, anelectrical malfunction, a controller malfunction, or a pump malfunction.

In a 19th example, the system of any of examples 1-18, wherein thetherapy data comprises at least one of an amount of insulin on board, atime of a delivery of glucose control therapy, or an amount of deliveryof glucose control therapy.

In a 20th example, the system of any of examples 1-19, wherein thetherapy data comprises version data comprising at least one of: atimestamp corresponding to a time associated with an update of thetherapy data; an indicator of an ordering within a sequence of deliveryof the glucose control therapy; or a version code comprising encodedtime data associated with delivery of the glucose control therapy.

In a 21st example, the system of any of examples 1-20, wherein theconfirmation signal indicates that the second ambulatory medicament pumpis in a ready state and that the first ambulatory medicament pump is notin a ready state.

In a 22nd example, the system of any of examples 1-21, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: in response to receiving the confirmation signal, turnoff a ready state of the first ambulatory medicament pump.

In a 23rd example, a method for transferring historical pump data from afirst ambulatory medicament pump to a second ambulatory medicament pump,the method comprising: by an electronic processor of a system executinginstructions stored on non-transitory memory connected to the electronicprocessor: receiving, via a data interface, the historical pump datafrom the first ambulatory medicament pump, wherein the historical pumpdata comprises: first encoded data corresponding to therapy dataassociated with delivery of glucose control therapy delivered by thefirst ambulatory medicament pump to the subject; and second encoded datacorresponding to a version data associated with the therapy data;decoding the first and second encoded data of the historical pump datato obtain the therapy data and the glucose control parameter;determining that at least one of a plurality of pairing conditions issatisfied to connect the data interface to the second ambulatorymedicament pump, wherein the plurality of pairing conditions comprises:a user request to pair the system to the second ambulatory medicamentpump; a user input initiating a replacement process for the firstambulatory medicament pump; an indication that the second ambulatorymedicament pump is ready to deliver medicament to the subject; a sensoryalarm configured to alert a user that the historical pump data is readyfor transmission; an alert indicating a malfunction associated with thefirst ambulatory medicament pump; a determination that a level ofmedicament in a medicament reservoir of the first ambulatory medicamentpump is below a threshold level; and a signal received from a remoteelectronic device requesting transmission of at least one of the therapydata or the glucose control parameter; transmitting, via the datainterface, a pairing signal to the second ambulatory medicament pump;receiving, via the data interface, a confirmation signal from the secondambulatory medicament pump; and in response to receiving theconfirmation signal, transmitting, via the data interface, at least oneof the therapy data or the glucose control parameter.

In a 24th example, the method of example 23, further comprising:generating, based on at least the therapy data and the glucose controlparameter, a dose control signal configured to cause a pump controllerof the first ambulatory medicament pump to deliver the medicament to thesubject.

In a 25th example, the method of example 24, wherein generating the dosecontrol signal comprises calculating regular correction boluses ofglucose control agent in response to at least the glucose controlparameter.

In a 26th example, the method of any of examples 23-25, furthercomprising: receiving third and fourth encoded data, the third encodeddata corresponding to a glucose level of a subject, and the fourthencoded data corresponding to an indication of a glucose trend, whereinthe glucose trend indicates at least a predicted change in the glucoselevel of the subject.

In a 27th example, the method of any of examples 23-26, furthercomprising: estimating a second glucose control parameter based on atleast one of the therapy data.

In a 28th example, the method of any of examples 23-27, furthercomprising: receiving, via the data interface, a glucose level signalfrom a glucose sensor operatively coupled to the subject; and estimatinga second glucose control parameter based on the glucose level signalreceived from the glucose sensor.

In a 29th example, the method of any of examples 23-28, furthercomprising transmitting to a graphical user interface, via the datainterface, one or more of the therapy data or the glucose controlparameter.

In a 30th example, the method of any of examples 23-29, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: transmitting to the remote electronic device, one or moreof the therapy data or the glucose control parameter.

In a 31st example, the method of example 30, wherein the remoteelectronic device comprises at least one of a mobile device or a remotecomputing environment.

In a 32nd example, the method of any of examples 23-31, wherein theglucose control parameter comprises at least one of: an insulin decayrate constant associated with a decay rate of insulin at a subcutaneousdepot of the subject; a clearance time associated with an estimate of anamount of time for a bolus of insulin to be utilized by the subject; aninsulin rise rate constant associated with a rise rate of insulin inblood of the subject after a bolus of insulin; a half-life valueassociated with when a concentration of insulin in blood plasma of thesubject reaches half of a maximum concentration in the blood plasma; aweight of the subject; an age of the subject; a learned parameter;glucose level data; a model parameter associated with a pharmacokinetic(PK) model; a health state of the subject; a parameter associated withan activity level of the subject; an aspect of a diet of the subject; abasal rate of insulin delivery to the subject; a correction factor; acarbohydrate ratio associated with the subject; a glucagon controlparameter; demographic information associated with the subject; and asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament.

In a 33rd example, the method of any of examples 23-32, wherein theinstructions, when executed by the hardware processor, are furtherconfigured to: receive, via the data interface, at least one of anamount of insulin on board or a value used in a pharmacokinetic (PK)model of a control algorithm.

In a 34th example, the method of any of examples 23-33, furthercomprising: transmitting to the second ambulatory medicament pump, inresponse to the confirmation signal, at least one of an amount ofinsulin on board or a value used in a pharmacokinetic (PK) model of acontrol algorithm.

In a 35th example, the method of any of examples 23-34, furthercomprising: determining that at least one of a plurality of dataretrieval conditions is satisfied to connect the data interface to thefirst ambulatory medicament pump, wherein the plurality of dataretrieval conditions comprises: an occurrence of a scheduled time; atransmission of a meal announcement; a user request to pair the systemto the first ambulatory medicament pump; the user input initiating areplacement process for the first ambulatory medicament pump; anindication that the first ambulatory pump is to be replaced; theindication that the second ambulatory medicament pump is ready todeliver medicament to the subject; the sensory alarm configured to alerta user that the historical pump data is ready for transmission; thealert indicating a malfunction associated with the first ambulatorymedicament pump; the determination that a level of medicament in amedicament reservoir of the first ambulatory medicament pump is below athreshold level; and the signal received from a remote electronic devicerequesting transmission of at least one of the therapy data or theglucose control parameter.

In a 36th example, the method of example 35, further comprising: inresponse to determining that the at least one of a plurality of dataretrieval conditions is satisfied, receiving from the first ambulatorymedicament pump, via the data interface, at least one of therapy data orthe glucose control parameter.

In a 37th example, the method of any of examples 23-36, wherein themalfunction associated with the first ambulatory medicament pumpcomprises at least one of an occlusion, a low battery power, anelectrical malfunction, a controller malfunction, or a pump malfunction.

In a 38th example, the method of any of examples 23-37, wherein thetherapy data comprises at least one of an amount of insulin on board, atime of a delivery of glucose control therapy, or an amount of deliveryof glucose control therapy.

In a 39th example, the method of any of examples 23-38, wherein theversion data comprises at least one of: a timestamp corresponding to atime associated with an update of the therapy data; an indicator of anordering within a sequence of delivery of the glucose control therapy;or a version code comprising encoded time data associated with deliveryof the glucose control therapy.

In a 40th example, the method of any of examples 23-39, wherein theconfirmation signal indicates that the second ambulatory medicament pumpis in a ready state and that the first ambulatory medicament pump is notin a ready state.

In a 41st example, the method of any of examples 23-40, furthercomprising: in response to receiving the confirmation signal, turningoff a ready state of the first ambulatory medicament pump.

In a 42nd example, an ambulatory medicament pump configured to store oneor more of a plurality of glucose control parameters and glucose controltherapy data on a removable data module configured to be readable by asecond ambulatory medicament pump, the ambulatory medicament pumpcomprising: a pump controller configured to direct medicament from amedicament reservoir to a subject; a module interface configured toreceive the removable data module; a non-transitory memory configured tostore specific computer-executable instructions; and an electronicprocessor in communication with the non-transitory memory and configuredto execute the specific computer-executable instructions to at least:determine the glucose control therapy data comprising at least one of anamount of insulin on board, a time of a delivery of glucose controltherapy, or an amount of delivery of glucose control therapy; generatethe one or more of the plurality of glucose control parameters, whereinthe plurality of glucose control parameters comprises: an insulin decayrate constant associated with a decay rate of insulin at a subcutaneousdepot of the subject; a clearance time associated with an estimate of anamount of time for a bolus of insulin to be utilized by the subject; aninsulin rise rate constant associated with a rise rate of insulin inblood of the subject after a bolus of insulin; a half-life valueassociated with when a concentration of insulin in blood plasma of thesubject reaches half of a maximum concentration in the blood plasma; aweight of the subject; an age of the subject; a learned parameter;glucose level data; a model parameter associated with a pharmacokinetic(PK) model; a health state of the subject; a parameter associated withan activity level of the subject; an aspect of a diet of the subject; abasal rate of insulin delivery to the subject; a correction factor; acarbohydrate ratio associated with the subject; a glucagon controlparameter; demographic information associated with the subject; and asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament; determine that the removable datamodule has been removed from the module interface; and in response todetermining that the removable data module has been removed, transmit anindication that the data module has been removed.

In a 43rd example, the ambulatory medicament pump of example 42, furthercomprising a data interface configured to receive a glucose level signalfrom a glucose sensor operatively coupled to the subject, wherein theglucose level signal comprises: first encoded data corresponding to theglucose level of the subject; and second encoded data corresponding toan indication of a glucose trend, wherein the glucose trend indicates atleast a predicted change in the glucose level of the subject.

In a 44th example, the ambulatory medicament pump of example 43, whereinthe electronic processor is further configured to execute the specificcomputer-executable instructions to at least: receive, via the datainterface, the glucose level signal from the glucose sensor; and decodethe first and second encoded data of the glucose level signal to obtainthe glucose level of the subject and the indication of the glucosetrend.

In a 45th example, the ambulatory medicament pump of any of examples42-44, wherein the electronic processor is further configured to executethe specific computer-executable instructions to at least: transmit to auser control element, via the data interface, an indication that theremovable data module is ready for removal.

In a 46th example, the ambulatory medicament pump of any of examples42-45, wherein the electronic processor is further configured to executethe specific computer-executable instructions to at least: generate,based on at least the one or more of the plurality of glucose controlparameters, a dose control signal configured to cause the pumpcontroller of the ambulatory medicament pump to deliver medicament tothe subject.

In a 47th example, the ambulatory medicament pump of example 46, whereingenerating the dose control signal comprises calculating regularcorrection boluses of glucose control agent in response to at least theone or more of the plurality of glucose control parameters.

In a 48th example, the ambulatory medicament pump of any of examples46-47, wherein the instructions, when executed by the hardwareprocessor, are further configured to: transmit to a remote electronicdevice, one or more of the glucose control therapy data or the glucosecontrol parameter.

In a 49th example, the ambulatory medicament pump of example 48, whereinthe remote electronic device comprises at least one of a mobile deviceor a remote computing environment.

In a 50th example, the ambulatory medicament pump of any of examples42-49, further comprising a graphical user interface configured todisplay at least one of the one or more of the plurality of glucosecontrol parameters or the glucose control therapy data.

In a 51st example, the ambulatory medicament pump of any of examples42-50, wherein the instructions, when executed by the hardwareprocessor, are further configured to: receive, via the data interface,at least one of an amount of insulin on board or a value used in apharmacokinetic (PK) model of a control algorithm.

In a 52nd example, the ambulatory medicament pump of any of examples42-51, wherein the data interface comprises a short-range wireless datainterface.

In a 53rd example, the ambulatory medicament pump of any of examples42-52, wherein the data interface comprises a plurality of datainterfaces.

In a 54th example, the ambulatory medicament pump of any of examples42-53, wherein the sensitivity constant comprises an indication of adate of diagnosis.

In a 55th example, the ambulatory medicament pump of any of examples42-54, wherein the instructions, when executed by the hardwareprocessor, are further configured to: execute, in response totransmitting the indication that the data module has been removed, apump deactivation process configured to deactivate the ambulatorymedicament pump.

In a 56th example, the ambulatory medicament pump of any of examples42-55, wherein the glucose control therapy data comprises version datacomprising at least one of: a timestamp corresponding to a timeassociated with an update of the glucose control therapy data; anindicator of an ordering within a sequence of delivery of the glucosecontrol therapy; or a version code comprising encoded time dataassociated with delivery of the glucose control therapy.

In a 57th example, a method for storing one or more of a plurality ofglucose control parameters and glucose control therapy data on aremovable data module of a first ambulatory medicament pump configuredto be readable by a second ambulatory medicament pump, the methodcomprising: by an electronic processor of the ambulatory medicament pumpexecuting instructions stored on non-transitory memory connected to theelectronic processor: determining the glucose control therapy datacomprising at least one of an amount of insulin on board, a time of adelivery of glucose control therapy, or an amount of delivery of glucosecontrol therapy; generating the one or more of the plurality of glucosecontrol parameters, wherein the plurality of glucose control parameterscomprises: an insulin decay rate constant associated with a decay rateof insulin at a subcutaneous depot of the subject; a clearance timeassociated with an estimate of an amount of time for a bolus of insulinto be utilized by the subject; an insulin rise rate constant associatedwith a rise rate of insulin in blood of the subject after a bolus ofinsulin; a half-life value associated with when a concentration ofinsulin in blood plasma of the subject reaches half of a maximumconcentration in the blood plasma; a weight of the subject; an age ofthe subject; a learned parameter; glucose level data; a model parameterassociated with a pharmacokinetic (PK) model; a health state of thesubject; a parameter associated with an activity level of the subject;an aspect of a diet of the subject; a basal rate of insulin delivery tothe subject; a correction factor; a carbohydrate ratio associated withthe subject; a glucagon control parameter; demographic informationassociated with the subject; and a sensitivity constant associated withthe subject's sensitivity to a glucose level or bolus of medicament;determining that the removable data module has been removed from themodule interface; and in response to determining that the removable datamodule has been removed, transmitting an indication that the data modulehas been removed.

In a 58th example, the method of example 57, further comprising:receiving, via the data interface, a glucose level signal from theglucose sensor, wherein the glucose level signal comprises: firstencoded data corresponding to the glucose level of the subject; andsecond encoded data corresponding to an indication of a glucose trend,wherein the glucose trend indicates at least a predicted change in theglucose level of the subject; and decoding the first and second encodeddata of the glucose level signal to obtain the glucose level of thesubject and the indication of the glucose trend.

In a 59th example, the method of any of examples 57-58, furthercomprising: transmitting to a user control element, via the datainterface, an indication that the removable data module is ready forremoval.

In a 60th example, the method of any of examples 57-59, furthercomprising: generating, based on at least the one or more of theplurality of glucose control parameters, a dose control signalconfigured to cause the pump controller of the ambulatory medicamentpump to deliver medicament to the subject.

In a 61st example, the method of example 60, wherein generating the dosecontrol signal comprises calculating regular correction boluses ofglucose control agent in response to at least the one or more of theplurality of glucose control parameters.

In a 62nd example, the method of any of examples 57-61, furthercomprising: transmitting to a remote electronic device, one or more ofthe glucose control therapy data or the one or more of the plurality ofglucose control parameters.

In a 63rd example, the method of example 62, wherein the remoteelectronic device comprises at least one of a mobile device or a remotecomputing environment.

In a 64th example, the method of any of examples 57-63, furthercomprising displaying at least one of the one or more of the pluralityof glucose control parameters or the glucose control therapy data.

In a 65th example, the method of any of examples 57-64, furthercomprising: receiving, via the data interface, at least one of an amountof insulin on board or a value used in a pharmacokinetic (PK) model of acontrol algorithm.

In a 66th example, the method of any of examples 57-65, wherein thesensitivity constant comprises an indication of a date of diagnosis.

In a 67th example, the method of any of examples 57-66, furthercomprising: executing, in response to transmitting the indication thatthe data module has been removed, a pump deactivation process configuredto deactivate the first ambulatory medicament pump.

In a 68th example, the method of any of examples 57-67, wherein theglucose control therapy data comprises version data comprising at leastone of: a timestamp corresponding to a time associated with an update ofthe glucose control therapy data; an indicator of an ordering within asequence of delivery of the glucose control therapy; or a version codecomprising encoded time data associated with delivery of the glucosecontrol therapy.

In a 69th example, an ambulatory medicament pump configured towirelessly transmit one or more of a plurality of glucose controlparameters and glucose control therapy data to a second ambulatorymedicament pump, the ambulatory medicament pump comprising: a pumpcontroller configured to direct medicament from a medicament reservoirto a subject; a data interface comprising a wireless data interfaceconfigured to transmit the one or more of the plurality of glucosecontrol parameters and the glucose control therapy data to the secondambulatory medicament pump; a non-transitory memory configured to storespecific computer-executable instructions; and an electronic processorin communication with the non-transitory memory and configured toexecute the specific computer-executable instructions to at least:determine the glucose control therapy data comprising at least one of anamount of insulin on board, a time of a delivery of glucose controltherapy, or an amount of delivery of glucose control therapy; generatethe one or more of the plurality of glucose control parameters, whereinthe plurality of glucose control parameters comprises: an insulin decayrate constant associated with a decay rate of insulin at a subcutaneousdepot of the subject; a clearance time associated with an estimate of anamount of time for a bolus of insulin to be utilized by the subject; aninsulin rise rate constant associated with a rise rate of insulin inblood of the subject after a bolus of insulin; a half-life valueassociated with when a concentration of insulin in blood plasma of thesubject reaches half of a maximum concentration in the blood plasma; aweight of the subject; an age of the subject; a learned parameter;glucose level data; a model parameter associated with a pharmacokinetic(PK) model; a health state of the subject; a parameter associated withan activity level of the subject; an aspect of a diet of the subject; abasal rate of insulin delivery to the subject; a correction factor; acarbohydrate ratio associated with the subject; a glucagon controlparameter; demographic information associated with the subject; and asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament; determine that at least one of aplurality of pairing conditions is satisfied to couple the ambulatorymedicament pump to the second ambulatory medicament pump, wherein theplurality of pairing conditions comprises: an occurrence of a scheduledtime; a transmission of a meal announcement; a user request to pair theambulatory medicament pump to a remote electronic device; a user inputinitiating a replacement process for the ambulatory medicament pump; anindication that the ambulatory medicament pump is to be replaced; anindication that the second ambulatory medicament pump is ready todeliver medicament to the subject; a sensory alarm configured to alert auser that historical pump data is ready for transmission; an alertindicating a malfunction associated with the ambulatory medicament pump;a determination that a level of medicament in a medicament reservoir ofthe ambulatory medicament pump is below a threshold level; adetermination that an amount of available medicament of the ambulatorymedicament pump is insufficient for a subject's medicament needs; and asignal received from the remote electronic device requestingtransmission of at least one of the glucose control therapy data or theone or more of the plurality of glucose control parameters; in responseto determining that the at least one of the plurality of pairingconditions is satisfied, wirelessly transmit, via the wireless datainterface, the one or more of the plurality of glucose controlparameters and the glucose control therapy data to the second ambulatorymedicament pump.

In a 70th example, the ambulatory medicament pump of example 69, whereinthe electronic processor is further configured to execute the specificcomputer-executable instructions to at least: transmit, via the wirelessdata interface, a pairing request signal to the second ambulatorymedicament pump.

In a 71st example, the ambulatory medicament pump of any of examples69-70, wherein the electronic processor is further configured to executethe specific computer-executable instructions to at least: receive, viathe wireless data interface, a pairing confirmation signal from thesecond ambulatory medicament pump.

In a 72nd example, the ambulatory medicament pump of any of examples69-71, wherein the data interface is further configured to receive aglucose level signal from a glucose sensor operatively coupled to thesubject, wherein the glucose level signal comprises: first encoded datacorresponding to the glucose level of the subject; and second encodeddata corresponding to an indication of a glucose trend, wherein theglucose trend indicates at least a predicted change in the glucose levelof the subject.

In a 73rd example, the ambulatory medicament pump of example 72, whereinthe electronic processor is further configured to execute the specificcomputer-executable instructions to at least: receive, via the datainterface, the glucose level signal from the glucose sensor; and decodethe first and second encoded data of the glucose level signal to obtainthe glucose level of the subject and the indication of the glucosetrend.

In a 74th example, the ambulatory medicament pump of any of examples69-73, wherein the electronic processor is further configured to executethe specific computer-executable instructions to at least: transmit to auser control element, via the data interface, an indication that thesecond ambulatory medicament pump is ready to be paired with theambulatory medicament pump.

In a 75th example, the ambulatory medicament pump of any of examples69-74, wherein the electronic processor is further configured to executethe specific computer-executable instructions to at least: generate,based on at least the one or more of the plurality of glucose controlparameters, a dose control signal configured to cause the pumpcontroller of the ambulatory medicament pump to deliver medicament tothe subject.

In a 76th example, the ambulatory medicament pump of example 75, whereingenerating the dose control signal comprises calculating regularcorrection boluses of glucose control agent in response to at least theone or more of the plurality of glucose control parameters.

In a 77th example, the ambulatory medicament pump of any of examples69-76, wherein the instructions, when executed by the hardwareprocessor, are further configured to: transmit to a remote electronicdevice, one or more of the glucose control therapy data or the one ormore of the plurality of glucose control parameters.

In a 78th example, the ambulatory medicament pump of example 77, whereinthe remote electronic device comprises at least one of a mobile deviceor a remote computing environment.

In a 79th example, the ambulatory medicament pump of any of examples69-78, further comprising a graphical user interface configured todisplay at least one of the glucose control therapy data or the one ormore of the plurality of glucose control parameters.

In an 80th example, the ambulatory medicament pump of any of examples69-79, wherein the instructions, when executed by the hardwareprocessor, are further configured to: receive, via the data interface,at least one of an amount of insulin on board or a value used in apharmacokinetic (PK) model of a control algorithm.

In an 81st example, the ambulatory medicament pump of any of examples69-80, wherein the wireless data interface comprises a short-rangewireless data interface.

In an 82nd example, the ambulatory medicament pump of any of examples69-81, wherein the data interface comprises a plurality of datainterfaces.

In an 83rd example, the ambulatory medicament pump of any of examples69-82, wherein the instructions, when executed by the hardwareprocessor, are configured to: transmit to the second ambulatorymedicament pump, in response to determining that the at least one of theplurality of pairing conditions is satisfied, at least one of an amountof insulin on board or a value used in a pharmacokinetic (PK) model of acontrol algorithm.

In an 84th example, the ambulatory medicament pump of any of examples69-83, wherein the instructions, when executed by the hardwareprocessor, are further configured to: in response to determining thatthe at least one of the plurality of pairing conditions is satisfied,receive from the remote electronic device, via the wireless datainterface, at least one glucose control parameter.

In an 85th example, the ambulatory medicament pump of any of examples69-84, wherein the malfunction associated with the first ambulatorymedicament pump comprises at least one of an occlusion, a low batterypower, an electrical malfunction, a controller malfunction, or a pumpmalfunction.

In an 86th example, the ambulatory medicament pump of any of examples69-85, wherein the sensitivity constant comprises an indication of adate of diagnosis.

In an 87th example, the ambulatory medicament pump of any of examples69-86, wherein the instructions, when executed by the hardwareprocessor, are configured to: execute, in response to transmitting theone or more of the plurality of glucose control parameters and theglucose control therapy data to the second ambulatory medicament pump, apump deactivation process configured to deactivate the first ambulatorymedicament pump.

In an 88th example, the ambulatory medicament pump of any of examples69-87, wherein the glucose control therapy data comprises version datacomprising at least one of: a timestamp corresponding to a timeassociated with an update of the glucose control therapy data; anindicator of an ordering within a sequence of delivery of the glucosecontrol therapy; or a version code comprising encoded time dataassociated with delivery of the glucose control therapy.

In an 89th example, a method for wirelessly transmitting from anambulatory medicament pump one or more of a plurality of glucose controlparameters and glucose control therapy data to a second ambulatorymedicament pump, the method comprising: by an electronic processor ofthe ambulatory medicament pump executing instructions stored onnon-transitory memory connected to the electronic processor: determiningthe glucose control therapy data comprising at least one of an amount ofinsulin on board, a time of a delivery of glucose control therapy, or anamount of delivery of glucose control therapy; generating the one ormore of the plurality of glucose control parameters, wherein theplurality of glucose control parameters comprises: an insulin decay rateconstant associated with a decay rate of insulin at a subcutaneous depotof the subject; a clearance time associated with an estimate of anamount of time for a bolus of insulin to be utilized by the subject; aninsulin rise rate constant associated with a rise rate of insulin inblood of the subject after a bolus of insulin; a half-life valueassociated with when a concentration of insulin in blood plasma of thesubject reaches half of a maximum concentration in the blood plasma; aweight of the subject; an age of the subject; a learned parameter;glucose level data; a model parameter associated with a pharmacokinetic(PK) model; a health state of the subject; a parameter associated withan activity level of the subject; an aspect of a diet of the subject; abasal rate of insulin delivery to the subject; a correction factor; acarbohydrate ratio associated with the subject; a glucagon controlparameter; demographic information associated with the subject; and asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament; determining that at least one of aplurality of pairing conditions is satisfied to couple the ambulatorymedicament pump to the second ambulatory medicament pump, wherein theplurality of pairing conditions comprises: an occurrence of a scheduledtime; a transmission of a meal announcement; a user request to pair theambulatory medicament pump to a remote electronic device; a user inputinitiating a replacement process for the ambulatory medicament pump; anindication that the ambulatory medicament pump is to be replaced; anindication that the second ambulatory medicament pump is ready todeliver medicament to the subject; a sensory alarm configured to alert auser that historical pump data is ready for transmission; an alertindicating a malfunction associated with the ambulatory medicament pump;a determination that a level of medicament in a medicament reservoir ofthe ambulatory medicament pump is below a threshold level; adetermination that an amount of available medicament of the ambulatorymedicament pump is insufficient for a subject's medicament needs; and asignal received from the remote electronic device requestingtransmission of at least one of the glucose control therapy data or theone or more of the plurality of glucose control parameters; in responseto determining that the at least one of the plurality of pairingconditions is satisfied, wirelessly transmitting, via a wireless datainterface, the one or more of the plurality of glucose controlparameters and the glucose control therapy data to the second ambulatorymedicament pump.

In a 90th example, the method of example 89, further comprising:transmitting, via the wireless data interface, a pairing request signalto the second ambulatory medicament pump.

In a 91st example, the method of any of examples 89-90, furthercomprising: receiving, via the wireless data interface, a pairingconfirmation signal from the second ambulatory medicament pump.

In a 92nd example, the method of any of examples 89-91, furthercomprising: receiving a glucose level signal from a glucose sensoroperatively coupled to the subject, wherein the glucose level signalcomprises: first encoded data corresponding to the glucose level of thesubject; and second encoded data corresponding to an indication of aglucose trend, wherein the glucose trend indicates at least a predictedchange in the glucose level of the subject; and decoding the first andsecond encoded data of the glucose level signal to obtain the glucoselevel of the subject and the indication of the glucose trend.

In a 93rd example, the method of any of examples 89-92, furthercomprising: transmitting to a user control element, via the datainterface, an indication that the second ambulatory medicament pump isready to be paired with the ambulatory medicament pump.

In a 94th example, the method of any of examples 89-93, furthercomprising: generating, based on at least the one or more of theplurality of glucose control parameters, a dose control signalconfigured to cause the pump controller of the ambulatory medicamentpump to deliver medicament to the subject.

In a 95th example, the method of example 94, wherein generating the dosecontrol signal comprises calculating regular correction boluses ofglucose control agent in response to at least the one or more of theplurality of glucose control parameters.

In a 96th example, the method of any of examples 89-95, furthercomprising: transmitting to a remote electronic device, one or more ofthe glucose control therapy data or the one or more of the plurality ofglucose control parameters.

In a 97th example, the method of example 96, wherein the remoteelectronic device comprises at least one of a mobile device or a remotecomputing environment.

In a 98th example, the method of any of examples 89-97, furthercomprising displaying at least one of the glucose control therapy dataor the one or more of the plurality of glucose control parameters.

In a 99th example, the method of any of examples 89-98, furthercomprising: receiving, via the data interface, at least one of an amountof insulin on board or a value used in a pharmacokinetic (PK) model of acontrol algorithm.

In a 100th example, the method of any of examples 89-99, furthercomprising: transmitting to the second ambulatory medicament pump, inresponse to determining that the at least one of the plurality ofpairing conditions is satisfied, at least one of an amount of insulin onboard or a value used in a pharmacokinetic (PK) model of a controlalgorithm.

In a 101st example, the method of any of examples 89-100, furthercomprising: in response to determining that the at least one of theplurality of pairing conditions is satisfied, receiving from the remoteelectronic device, via the wireless data interface, at least one glucosecontrol parameter.

In a 102nd example, the method of any of examples 89-101, wherein themalfunction associated with the first ambulatory medicament pumpcomprises at least one of an occlusion, a low battery power, anelectrical malfunction, a controller malfunction, or a pump malfunction.

In a 103rd example, the method of any of examples 89-102, wherein thesensitivity constant comprises an indication of a date of diagnosis.

In a 104th example, the method of any of examples 89-103, furthercomprising: executing, in response to transmitting the one or more ofthe plurality of glucose control parameters and the glucose controltherapy data to the second ambulatory medicament pump, a pumpdeactivation process configured to deactivate the first ambulatorymedicament pump.

In a 105th example, the method of any of examples 89-104, wherein theglucose control therapy data comprises version data comprising at leastone of: a timestamp corresponding to a time associated with an update ofthe glucose control therapy data; an indicator of an ordering within asequence of delivery of the glucose control therapy; or a version codecomprising encoded time data associated with delivery of the glucosecontrol therapy.

In a 106th example, a glucose level control system configured togenerate a configuration code derived from medicament therapyadministered to a subject, the configuration code configured tocustomize glucose level control therapy, the glucose level controlsystem comprising: a medicament delivery interface configured tooperatively connect to an ambulatory medicament pump for infusingmedicament into the subject; a non-transitory memory configured to storespecific computer-executable instructions; and an electronic processorin communication with the non-transitory memory and configured toexecute the specific computer-executable instructions to at least: trackmedicament therapy administered to the subject over a tracking period bythe glucose level control system, wherein tracking the medicamenttherapy comprises storing an indication of doses of medicament deliveredto the subject as correction boluses of medicament, as food intakeboluses of medicament, or as basal doses of medicament; generate theconfiguration code comprising at least one of a plurality of encodeddosing parameters, wherein the plurality of encoded dosing parameterscomprises: a correction dosing parameter based on at least some of thecorrection boluses of medicament administered during the trackingperiod; a food intake dosing parameter comprising an indication of afood intake bolus size of medicament based on one or more food intakeboluses provided during the tracking period; and a basal dosingparameter based on at least some of the basal doses of medicamentadministered during the tracking period; and output the configurationcode as determined by the glucose level control system for the purposeof being used when the glucose level control system is replaced with asecond glucose level control system, wherein the configuration codecustomizes at least initial therapy provided by the second glucose levelcontrol system.

In a 107th example, the glucose level control system of example 106,wherein the electronic processor is further configured to execute thespecific computer-executable instructions to at least receive glucoselevel data from a sensor operatively configured to determine glucoselevels in the subject.

In a 108th example, the glucose level control system of example 107,wherein the at least one of the plurality of encoded dosing parametersis based on at least the glucose level data received during the trackingperiod.

In a 109th example, the glucose level control system of any of examples106-108, wherein the at least one of the plurality of encoded dosingparameters comprises the basal dosing parameter and the food intakedosing parameter.

In a 1200th example, the glucose level control system of any of examples106-109, wherein the at least one of the plurality of encoded dosingparameters comprises the basal dosing parameter, the correction dosingparameter, and the food intake dosing parameter.

In a 111th example, the glucose level control system of any of examples106-110, wherein the configuration code further comprises a subjectidentifier.

In a 112th example, the glucose level control system of any of examples106-111, wherein the configuration code further comprises a time-basedparameter.

In a 113th example, the glucose level control system of example 112,wherein the time-based parameter comprises a timestamp indicating atleast one of an age of the configuration code, an age of the trackingperiod, or an expiration date of the configuration code.

In a 114th example, the glucose level control system of any of examples106-113, wherein the doses of medicament are determined based on atleast one of physiological parameters, demographic parameters, or foodintake parameters of the subject.

In a 115th example, the glucose level control system of any of examples106-114, wherein the food intake dosing parameter includes a pluralityof calculated food intake dose amounts, and wherein at least onecalculated food intake dose amount corresponds to a segment of a daydifferent from at least one other calculated food intake dose amount ofthe plurality of calculated food intake dose amounts.

In a 116th example, the glucose level control system of any of examples106-115, wherein a basal rate used to generate the basal doses ofmedicament is adapted over time based at least in part on one or moreglucose level signals received from a sensor operatively configured todetermine glucose levels in the subject.

In a 117th example, the glucose level control system of any of examples106-116, wherein a food intake bolus size used to generate the foodintake boluses of medicament is adapted over time based at least in parton one or more glucose level signals received from a sensor operativelyconfigured to determine glucose levels in the subject.

In a 118th example, the glucose level control system of any of examples106-117, wherein a length of the configuration code is 16 characters ormore.

In a 119th example, the glucose level control system of any of examples106-118, wherein a length of the configuration code is 16 bytes or more.

In a 120th example, the glucose level control system of any of examples106-119, wherein outputting the configuration code comprisestransmitting the configuration code to the second glucose level controlsystem or to an electronic device in communication with the glucoselevel control system.

In a 121st example, the glucose level control system of example 120,wherein the electronic processor is further configured to execute thecomputer-executable instructions to at least generate a checksum forchecking an error in the transmission of the configuration code.

In a 122nd example, the glucose level control system of any of examples120-121, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at leastwirelessly transmit the configuration code to the second glucose levelcontrol system or to the electronic device.

In a 123rd example, the glucose level control system of any of examples106-122, wherein outputting the configuration code comprises outputtingthe configuration code on a user interface of the glucose level controlsystem.

In a 124th example, the glucose level control system of any of examples106-123, wherein the configuration code is output as part of a backuptherapy protocol.

In a 125th example, the glucose level control system of any of examples106-124, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at leastreceive a second configuration code comprising an encoded dosingparameter.

In a 126th example, the glucose level control system of example 125,wherein the electronic processor is further configured to execute thespecific computer-executable instructions to at least: determine, basedon the encoded dosing parameter, a value for a control parameter used bya control algorithm that generates dose control signals to providemedicament therapy to the subject; and configure the control parameterbased on the value determined from the encoded dosing parameter.

In a 127th example, the glucose level control system of example 126,wherein the electronic processor is further configured to determine thevalue for the control parameter by at least decrypting the encodeddosing parameter.

In a 128th example, the glucose level control system of any of examples126-127, wherein electronic processor is further configured to configurethe control parameter by setting the control parameter to the valuedetermined from the encoded dosing parameter.

In a 129th example, the glucose level control system of any of examples126-128, wherein the value comprises an initial value for the controlparameter, and wherein the control parameter is adapted over time basedat least in part on the medicament therapy administered over thetracking period.

In a 130th example, the glucose level control system of any of examples125-129, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least:verify a checksum of the second configuration code; and responsive tosuccessfully verifying the checksum of the second configuration code,configure a control parameter based at least in part on the secondconfiguration code, wherein the control parameter used by a controlalgorithm that generates dose control signals to provide medicamenttherapy to the subject.

In a 131st example, the glucose level control system of any of examples125-130, wherein electronic processor is further configured to generatethe configuration code by updating the second configuration code basedat least in part on the tracked medicament therapy.

In a 132nd example, the glucose level control system of any of examples125-131, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least:determine a first reference code associated with the secondconfiguration code; determine a second reference code associated withthe glucose level control system; and responsive to determining that thefirst reference code matches the second reference code, configure acontrol parameter based at least in part on the second configurationcode, wherein the control parameter used by a control algorithm thatgenerates dose control signals to provide medicament therapy to thesubject.

In a 133rd example, the glucose level control system of example 132,wherein the first reference code and the second reference codecorrespond to one or more versions of control software capable of beingexecuted by one or more glucose level control systems.

In a 134th example, the glucose level control system of any of examples132-133, wherein, responsive to determining that the first referencecode does not match the second reference code, the electronic processoris further configured to execute the specific computer-executableinstructions to at least maintain an existing value of the controlparameter.

In a 135th example, the glucose level control system of any of examples132-134, wherein, responsive to determining that the first referencecode does not match the second reference code, the electronic processoris further configured to execute the specific computer-executableinstructions to at least configure the control parameter based at leastin part on a modified version of the second configuration code.

In a 136th example, the glucose level control system of any of examples125-135, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least:determine, based on the encoded dosing parameter, a value for a controlparameter used by a control algorithm that generates dose controlsignals to provide medicament therapy to the subject; determine whetherthe value is safe for the subject; and responsive to determining thatthe value is safe for the subject, configure the control parameter basedon the value determined from the encoded dosing parameter.

In a 137th example, the glucose level control system of example 136,wherein the electronic processor is further configured to determinewhether the value is safe for the subject by determining whether thevalue is within a threshold range for a historical value for the controlparameter.

In a 138th example, the glucose level control system of example 137,wherein the historical value comprises an average value over aparticular time period or a most recent value of the control parameter.

In a 139th example, the glucose level control system of any of examples137-138, wherein the historical value is obtained based on a history ofmedicament therapy stored at the glucose level control system.

In a 140th example, the glucose level control system of any of examples137-139, wherein the historical value is obtained based on a history ofmedicament therapy stored at an electronic device in communication withthe glucose level control system.

In a 141st example, the glucose level control system of any of examples125-140, wherein the second configuration code is received in responseto a user interaction with a user interface of the glucose level controlsystem.

In a 142nd example, the glucose level control system of any of examples125-141, wherein the second configuration code is received from anelectronic computing device in communication with the glucose levelcontrol system.

In a 143rd example, the glucose level control system of example 142,wherein the second configuration code is received from the electroniccomputing device in response to a request from the glucose level controlsystem.

In a 144th example, the glucose level control system of any of examples106-143, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at leastencrypt the configuration code, and wherein outputting the configurationcode comprises outputting the encrypted configuration code.

In a 145th example, the glucose level control system of any of examples106-144, wherein the configuration code is associated with a serialnumber corresponding to the glucose level control system.

In a 146th example, a computer-implemented method of generating aconfiguration code derived from medicament therapy administered to asubject, the configuration code configured to customize glucose levelcontrol therapy, the computer-implemented method comprising: by ahardware processor of a glucose level control system configured toprovide medicament therapy to the subject, tracking the medicamenttherapy administered to the subject over a tracking period by theglucose level control system, wherein tracking the medicament therapycomprises storing an indication of doses of medicament delivered to thesubject as correction boluses of medicament, as food intake boluses ofmedicament, or as basal doses of medicament; generating theconfiguration code comprising at least one of a plurality of encodeddosing parameters, wherein the plurality of encoded dosing parameterscomprises: a correction dosing parameter based on at least some of thecorrection boluses of medicament administered during the trackingperiod; a food intake dosing parameter comprising an indication of afood intake bolus size of medicament based on one or more food intakeboluses provided during the tracking period; a basal dosing parameterbased on at least some of the basal doses of medicament administeredduring the tracking period; a carbohydrate ratio comprising anindication of a quantity of medicament to administer per quantity ofcarbohydrates consumed or to be consumed; a correction factor comprisingan indication of how much a quantity of medicament will affect or ispredicted to affect a glucose level of the subject; a basal ratecomprising an indication of a rate of medicament to administer over atime period; a counter-regulatory agent dosing parameter comprising anindication of a quantity of a counter-regulatory agent based on one ormore counter-regulatory agent boluses administered during the trackingperiod; a control parameter based on execution of a control algorithmduring the tracking period; and a setting parameter used by the glucoselevel control system in identifying the subject or configuring theglucose level control system during the tracking period; and outputtingthe configuration code as determined by the glucose level control systemfor the purpose of being used when the glucose level control system isreplaced with a second glucose level control system, wherein theconfiguration code customizes at least initial therapy provided by thesecond glucose level control system.

In a 147th example, the computer-implemented method of example 146,wherein the setting parameter comprises a subject identifier of thesubject, an alert setting, a medicament pump setting, a user interfacesetting, a security setting, a safe-access level setting, state data ofthe glucose level control system, or a user identifier of a userassociated with the subject.

In a 148th example, the computer-implemented method of any of examples146-147, wherein the counter-regulatory agent comprises glucagon.

In a 149th example, the computer-implemented method of any of examples146-148, wherein the food intake dosing parameter corresponds to aparticular meal.

In a 150th example, a glucose level control system configured to modifycontrol parameters based on a configuration code generated based onprior medicament therapy administered to a subject, the configurationcode configured to customize glucose level control therapy, the glucoselevel control system comprising: a medicament delivery interfaceconfigured to operatively connect to an ambulatory medicament pump forinfusing medicament into the subject; a non-transitory memory configuredto store specific computer-executable instructions; and an electronicprocessor in communication with the non-transitory memory and configuredto execute the specific computer-executable instructions to at least:receive the configuration code comprising at least one of a plurality ofencoded dosing parameters, wherein the plurality of encoded dosingparameters correspond to a set of dosing parameters comprising: acorrection dosing parameter used by a control algorithm to determine acorrection bolus of medicament to administer to the subject; a foodintake dosing parameter used by the control algorithm to determine afood intake bolus size of medicament to administer to the subject; and abasal dosing parameter used by the control algorithm to determine abasal rate of medicament to administer to the subject; decode theconfiguration code to identify a dosing parameter and a value of thedosing parameter, wherein the dosing parameter is one of the set ofdosing parameters; and configure a control parameter of the controlalgorithm corresponding to the dosing parameter based on the value ofthe dosing parameter.

In a 151st example, the glucose level control system of example 150,wherein the electronic processor is further configured to decode theconfiguration code by decrypting the configuration code.

In a 152nd example, the glucose level control system of any of examples150-151, wherein the electronic processor is further configured toconfigure the control parameter by setting the control parameter to thevalue identified from the configuration code.

In a 153rd example, the glucose level control system of any of examples150-152, wherein the value comprises an initial value for the controlparameter, and wherein the control parameter is adapted over a timeperiod based at least in part on medicament therapy administered overthe time period.

In a 154th example, the glucose level control system of any of examples150-153, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least verifya checksum of the configuration code prior to decoding the configurationcode.

In a 155th example, the glucose level control system of any of examples150-154, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least:update the configuration code based on medicament therapy provided overa tracking period; and output the updated configuration code enabling asecond glucose level control system to be configured based at least inpart on the updated configuration code.

In a 156th example, the glucose level control system of any of examples150-155, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least verifythat a reference code of the glucose level control system matches areference code of the configuration code prior to configuring thecontrol parameter of the control algorithm.

In a 157th example, the glucose level control system of example 156,wherein the reference code of the glucose level control systemcomprises: a serial number, a software version number, or a modelnumber.

In a 158th example, the glucose level control system of any of examples150-157, wherein the electronic processor is further configured toidentify the value of the control parameter by at least: determining areference to a server from the configuration code; and accessing theserver to obtain the value of the control parameter.

In a 159th example, the glucose level control system of example 158,wherein the server stores one or more values of one or more dosingparameters associated with the subject or a demographic that includesthe subject.

In a 160th example, the glucose level control system of any of examples150-159, wherein the configuration code is received in response to auser interaction with a user interface of the glucose level controlsystem.

In a 161st example, the glucose level control system of any of examples150-160, wherein the configuration code is received from an electronicdevice in communication with the glucose level control system.

In a 162nd example, the glucose level control system of example 161,wherein the electronic processor is further configured to execute thespecific computer-executable instructions to at least access an accountof the subject at the electronic device, and wherein the configurationcode is associated with the account of the subject.

In a 163rd example, the glucose level control system of example 162,wherein the account comprises an electronic health record of thesubject.

In a 164th example, the glucose level control system of any of examples150-163, wherein the configuration code is associated with the subjector a demographic that includes the subject.

In a 165th example, the glucose level control system of any of examples150-164, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at leastdetermine whether the value of the dosing parameter is safe for thesubject.

In a 166th example, the glucose level control system of example 165,wherein the electronic processor determines whether the value of thedosing parameter is safe for the subject be at least determining aprobability that the value of the dosing parameter will cause ahypoglycemic or hyperglycemic event.

In a 167th example, the glucose level control system of any of examples150-166, wherein the configuration code is received during aninitialization process of the glucose level control system.

In a 168th example, the glucose level control system of any of examples150, wherein the configuration code is received from the non-transitorymemory.

In a 169th example, a computer-implemented method of modifying controlparameters based on a configuration code generated based on priormedicament therapy administered to a subject, the configuration codeconfigured to customize glucose level control therapy, thecomputer-implemented method comprising: by a hardware processor of aglucose level control system configured to provide medicament therapy tothe subject, receiving the configuration code comprising at least one ofa plurality of encoded dosing parameters, wherein the plurality ofencoded dosing parameters correspond to a set of dosing parameterscomprising: a correction dosing parameter used by a control algorithm todetermine a correction bolus of medicament to administer to the subject;a food intake dosing parameter used by the control algorithm todetermine a food intake bolus size of medicament to administer to thesubject; and a basal dosing parameter used by the control algorithm todetermine a basal rate of medicament to administer to the subject;decoding the configuration code to identify a dosing parameter and avalue of the dosing parameter, wherein the dosing parameter is one ofthe set of dosing parameters; and configuring a control parameter of thecontrol algorithm corresponding to the dosing parameter based on thevalue of the dosing parameter.

In a 170th example, an electronic device configured to generate aconfiguration code derived from medicament therapy administered to asubject, the configuration code configured to customize glucose levelcontrol therapy, the electronic device comprising: a network interfaceconfigured to receive medicament therapy data; and a non-transitorymemory configured to store specific computer-executable instructions;and an electronic processor in communication with the non-transitorymemory and configured to execute the specific computer-executableinstructions to at least: receive medicament therapy data from a glucoselevel control system configured to administer medicament therapy to asubject, wherein the medicament therapy data corresponds to themedicament therapy administered to the subject over a tracking period,and wherein the medicament therapy data comprises an indication of dosesof medicament delivered to the subject as correction boluses ofmedicament, as food intake boluses of medicament, or as basal doses ofmedicament; generate the configuration code comprising at least one of aplurality of encoded dosing parameters, wherein the plurality of encodeddosing parameters comprises: a correction dosing parameter based on atleast some of the correction boluses of medicament administered duringthe tracking period; a food intake dosing parameter comprising anindication of a food intake bolus size of medicament based on one ormore food intake boluses provided during the tracking period; and abasal dosing parameter based on at least some of the basal doses ofmedicament administered during the tracking period; and transmit theconfiguration code to a second glucose level control system enabling thesecond glucose level control system to be customized with an initialconfiguration based at least in part on the configuration code.

In a 171st example, the electronic device of example 170, wherein theelectronic device comprises a server of a networked computingenvironment.

In a 172nd example, the electronic device of any of examples 170-171,wherein the electronic device comprises a distributed computing system.

In a 173rd example, the electronic device of any of examples 170-172,wherein generating the configuration code further comprises generating achecksum to include with the configuration code.

In a 174th example, the electronic device of any of examples 170-173,wherein the medicament therapy data is received by the network interfaceover a wireless or cellular network.

In a 175th example, a computer-implemented method of generating aconfiguration code derived from medicament therapy administered to asubject, the configuration code configured to customize glucose levelcontrol therapy, the computer-implemented method comprising: by ahardware processor of an electronic device that communicates over anetwork with a glucose level control system configured to providemedicament therapy to the subject, receiving medicament therapy datafrom the glucose level control system configured to administermedicament therapy to a subject, wherein the medicament therapy datacorresponds to the medicament therapy administered to the subject over atracking period, and wherein the medicament therapy data comprises anindication of doses of medicament delivered to the subject as correctionboluses of medicament, as food intake boluses of medicament, or as basaldoses of medicament; generating the configuration code comprising atleast one of a plurality of encoded dosing parameters, wherein theplurality of encoded dosing parameters comprises: a correction dosingparameter based on at least some of the correction boluses of medicamentadministered during the tracking period; a food intake dosing parametercomprising an indication of a food intake bolus size of medicament basedon one or more food intake boluses provided during the tracking period;and a basal dosing parameter based on at least some of the basal dosesof medicament administered during the tracking period; and transmittingthe configuration code to a second glucose level control system enablingthe second glucose level control system to be customized with an initialconfiguration based at least in part on the configuration code.

In a 176th example, a blood glucose control system configured to receivea glucose level signal from a glucose sensor operatively coupled to thesubject and to calculate a dose control signal for commandingadministration of glucose control therapy to a subject via a pumpcontroller of an ambulatory medicament pump operatively coupled to thesubject, the blood glucose control system comprising: a data interfaceconfigured to transmit the dose control signal to the pump controllerand to receive the glucose level signal from the glucose sensor, whereinthe glucose level signal comprises: first encoded data corresponding toa glucose level of the subject; and second encoded data corresponding toan indication of a glucose trend, wherein the glucose trend indicates atleast a predicted change in the glucose level of the subject; anon-transitory memory configured to store specific computer-executableinstructions; and an electronic processor in communication with thenon-transitory memory and configured to execute the specificcomputer-executable instructions to at least: receive, via the datainterface, the glucose level signal from the glucose sensor operativelycoupled to the subject; decode the first and second encoded data of theglucose level signal to obtain the glucose level of the subject and theindication of the glucose trend; calculate the dose control signal usinga control algorithm configured to calculate regular correction bolusesof glucose control agent in response to at least the glucose level ofthe subject; select a dose control signal encoding profile from aplurality of dose control signal encoding profiles, wherein each of theplurality of dose control signal encoding profiles corresponds to atleast one of a plurality of pump controllers, wherein each dose controlsignal encoding profile is configured to encode the dose control signalfor transmission to the pump controller, and wherein the selected dosecontrol signal encoding profile corresponds to the pump controlleroperatively coupled to the subject; encode the dose control signal usingthe selected dose control signal encoding profile such that the pumpcontroller can read the dose control signal; and transmit the encodeddose control signal to the pump controller of the ambulatory medicamentpump, wherein the dose control signal commands the ambulatory medicamentpump to administer glucose control therapy via infusion of the glucosecontrol agent into the subject.

In a 177th example, the blood glucose control system of example 176,further comprising a graphical user interface configured to display theglucose level of the subject or the indication of the glucose trend,wherein the instructions, when executed by the hardware processor, arefurther configured to: transmit, via the data interface to the graphicaluser interface, one or more of the glucose level of the subject or theindication of the glucose trend.

In a 178th example, the blood glucose control system of any of examples176-177, wherein the instructions, when executed by the hardwareprocessor, are further configured to transmit the glucose level of thesubject or the indication of the glucose trend to a remote electronicdevice.

In a 179th example, the blood glucose control system of example 178,wherein the remote electronic device comprises at least one of a mobiledevice or a remote computing environment.

In a 180th example, the blood glucose control system of any of examples176-179, wherein the instructions, when executed by the hardwareprocessor, are further configured to receive, from the glucose sensor,via the data interface, blood glucose control parameters comprising atleast one of: an insulin decay rate constant associated with a decayrate of insulin at a subcutaneous depot of the subject; a clearance timeassociated with an estimate of an amount of time for a bolus of insulinto be utilized by the subject; an insulin rise rate constant associatedwith a rise rate of insulin in blood of the subject after a bolus ofinsulin; a time value associated with when a concentration of insulin inblood plasma of the subject reaches a threshold concentration in theblood plasma; or a sensitivity constant associated with the subject'ssensitivity to a glucose level or bolus of medicament.

In a 181st example, the blood glucose control system of any of examples176-180, wherein the instructions, when executed by the hardwareprocessor, are further configured to: receive, via the data interface,at least one of an amount of insulin on board or a value used in apharmacokinetic (PK) model of the control algorithm.

In a 182nd example, the blood glucose control system of any of examples176-181, further comprising the ambulatory medicament pump and the pumpcontroller.

In a 183rd example, the blood glucose control system of any of examples176-182, wherein the instructions, when executed by the hardwareprocessor, are configured to execute the control algorithm.

In a 184th example, the blood glucose control system of any of examples176-183, wherein the data interface comprises a short-range wirelessdata interface.

In a 185th example, the blood glucose control system of any of examples176-184, wherein the instructions, when executed by the hardwareprocessor, are further configured to: select a glucose level signaldecoding profile from a plurality of glucose level signal decodingprofiles, wherein each of the plurality of glucose level signal decodingprofiles corresponds to at least one of a plurality of glucose sensors,wherein each glucose level signal decoding profile is configured todecode at least the first encoded data and the second encoded data ofthe glucose level signal, and wherein the selected glucose level signaldecoding profile corresponds to the glucose sensor operatively coupledto the subject; and decode the first and second encoded data of theglucose level signal using the selected glucose level signal decodingprofile.

In a 186th example, the blood glucose control system of any of examples176-185, wherein the data interface comprises a plurality of datainterfaces.

In a 187th example, a disposable ambulatory medicament pump configuredto administer blood glucose control therapy to a subject and to transmitblood glucose control parameters to a remote electronic device inresponse to an identification of a triggering condition, the disposableambulatory medicament pump comprising: a medicament reservoir configuredto store medicament to be delivered through a cannula into asubcutaneous depot of the subject as at least a portion of the bloodglucose control therapy; a pump controller configured to direct themedicament from the medicament reservoir to the subject via thedisposable ambulatory medicament pump; a data interface configured toreceive a glucose level signal from a glucose sensor and to transmit theblood glucose control parameters to the remote electronic device; anon-transitory memory configured to store specific computer-executableinstructions and the blood glucose control parameters; and an electronicprocessor in communication with the non-transitory memory and configuredto execute the specific computer-executable instructions to at least:receive, via the data interface, the glucose level signal from theglucose sensor operatively coupled to the subject; generate the bloodglucose control parameters based on trends in the blood glucose controltherapy and the glucose level signal using a control parameter selectionprocess over a therapy period spanning at least hours to days; generate,based on at least the glucose level signal and the blood glucose controlparameters, a dose control signal configured to cause the pumpcontroller to administer the blood glucose control therapy to thesubject; identify that at least one of a plurality of triggeringconditions is satisfied, the at least one of the plurality of triggeringconditions configured to prompt transmission of the blood glucosecontrol parameters to the remote electronic device, the plurality oftriggering conditions comprising: a sensory alarm configured to alert auser that the blood glucose control parameters are ready fortransmission; a determination that a level of medicament in themedicament reservoir is below a threshold level; a signal received fromthe remote electronic device requesting transmission of the bloodglucose control parameters; and a user-generated indication to replacethe disposable ambulatory medicament pump; and based on the satisfactionof the at least one of the plurality of triggering conditions, transmitthe blood glucose control parameters to the remote electronic device.

In a 188th example, the disposable ambulatory medicament pump of example187, wherein the blood glucose control parameters comprise at least oneof a glucose level or an indication of a glucose trend of the subject.

In a 189th example, the disposable ambulatory medicament pump of any ofexamples 187-188, wherein the blood glucose control parameters compriseat least one of: an insulin decay rate constant associated with a decayrate of insulin at a subcutaneous depot of the subject; a clearance timeassociated with an estimate of an amount of time for a bolus of insulinto be utilized by the subject; an insulin rise rate constant associatedwith a rise rate of insulin in blood of the subject after a bolus ofinsulin; a time value associated with when a concentration of insulin inblood plasma of the subject reaches a threshold concentration in theblood plasma; or a sensitivity constant associated with the subject'ssensitivity to a glucose level or bolus of medicament.

In a 190th example, the disposable ambulatory medicament pump of any ofexamples 187-189, wherein the instructions, when executed by thehardware processor, are further configured to: transmit, based on thesatisfaction of the at least one of the plurality of triggeringconditions, at least one of an amount of insulin on board or a valueused in a pharmacokinetic (PK) model of a control algorithm.

In a 191st example, the disposable ambulatory medicament pump of any ofexamples 187-190, wherein the triggering condition comprises the sensoryalarm configured to alert a user that the blood glucose controlparameters are ready for transmission.

In a 192nd example, the disposable ambulatory medicament pump of example191, wherein the sensory alarm is configured to regularly orperiodically alert the user until the blood glucose control parametersare transferred to the remote electronic device.

In a 193rd example, the disposable ambulatory medicament pump of any ofexamples 187-192, wherein the instructions, when executed by thehardware processor, are configured to: generate the blood glucosecontrol parameters further based on a glycemic response of the subjectover a therapy interval.

In a 194th example, the disposable ambulatory medicament pump of any ofexamples 187-193, wherein the therapy interval comprises between about10 seconds and 10 minutes.

In a 195th example, the disposable ambulatory medicament pump of any ofexamples 187-194, wherein the instructions, when executed by thehardware processor, are configured to: generate the blood glucosecontrol parameters further based on glycemic response of the subject toa medicament bolus.

In a 196th example, the disposable ambulatory medicament pump of any ofexamples 187-195, wherein the instructions, when executed by thehardware processor, are configured to: generate the blood glucosecontrol parameters by learning the blood glucose control parametersduring online operation of an automated blood glucose control system.

In a 197th example, the disposable ambulatory medicament pump of any ofexamples 196-196, wherein generating the blood glucose controlparameters comprises at least one of: calculating a size of a correctionbolus of insulin of the regular correction boluses at a time ofreceiving an isolated glucose measurement from the glucose sensor.

In a 198th example, the disposable ambulatory medicament pump of any ofexamples 196-197, wherein generating the blood glucose controlparameters comprises at least one of: calculating a size of a meal bolusof insulin.

In a 199th example, the disposable ambulatory medicament pump of any ofexamples 187-198, wherein the instructions, when executed by thehardware processor, are configured to: generating the blood glucosecontrol parameters using a control algorithm.

In a 200th example, the disposable ambulatory medicament pump of any ofexamples 187-199, wherein the remote electronic device comprises amobile device.

In a 201st example, the disposable ambulatory medicament pump of any ofexamples 187-200, wherein the remote electronic device comprises aremote computing environment.

In a 202nd example, the disposable ambulatory medicament pump of any ofexamples 187-201, wherein the data interface comprises a short-rangewireless data interface.

In a 203rd example, a method for administering blood glucose controltherapy to a subject and transmitting blood glucose control parametersto a remote electronic device in response to an identification of atriggering condition, the method comprising: by an electronic processorof a blood glucose control system executing instructions stored onnon-transitory memory connected to the electronic processor: receiving,via a data interface, a glucose level signal from a glucose sensoroperatively coupled to the subject; calculating, based on the glucoselevel signal, a dose control signal configured to cause a pumpcontroller to administer at least a portion of blood glucose controltherapy into a subcutaneous depot of the subject; generating the bloodglucose control parameters based on the blood glucose control therapyand the dose control signal; identifying that at least one of aplurality of triggering conditions is satisfied, the at least one of theplurality of triggering conditions configured to prompt transmission ofthe blood glucose control parameters to the remote electronic device,the plurality of triggering conditions comprising: a sensory alarmconfigured to alert a user that the blood glucose control parameters areready for transmission; a determination that a level of medicament inthe medicament reservoir is below a threshold level; a signal receivedfrom the remote electronic device requesting transmission of the bloodglucose control parameters; and a user-generated indication to replacethe disposable ambulatory medicament pump; and based on the satisfactionof the at least one of the plurality of triggering conditions,transmitting the blood glucose control parameters to the remoteelectronic device.

In a 204th example, the method of example 203, wherein the glucose levelsignal comprises at least one of a glucose level or an indication of aglucose trend of the subject.

In a 205th example, the method of any of examples 203-204, wherein theblood glucose control parameters comprise at least one of: an insulindecay rate constant associated with a decay rate of insulin at asubcutaneous depot of the subject; a clearance time associated with anestimate of an amount of time for a bolus of insulin to be utilized bythe subject; an insulin rise rate constant associated with a rise rateof insulin in blood of the subject after a bolus of insulin; a timevalue associated with when a concentration of insulin in blood plasma ofthe subject reaches a threshold concentration in the blood plasma; or asensitivity constant associated with the subject's sensitivity to aglucose level or bolus of medicament.

In a 206th example, the method of any of examples 203-205, furthercomprising: transmitting, based on the satisfaction of the at least oneof the plurality of triggering conditions, at least one of an amount ofinsulin on board or a value used in a pharmacokinetic (PK) model.

In a 207th example, the method of any of examples 203-206, wherein thetriggering condition comprises the sensory alarm configured to alert auser that the blood glucose control parameters are ready fortransmission.

In a 208th example, the method of example 207, wherein the sensory alarmis configured to regularly or periodically alert the user until theblood glucose control parameters are transferred to the remoteelectronic device.

In a 209th example, the method of any of examples 203-208, furthercomprising: generating the blood glucose control parameters furtherbased on glycemic response of the subject to a medicament bolus.

In a 210th example, a blood glucose control system configured to receivean encoded pump status signal and an encoded medicament delivery signalfrom a pump controller operatively coupled to an ambulatory medicamentpump and to calculate a dose control signal for commandingadministration of glucose control therapy to a subject via theambulatory medicament pump, the blood glucose control system comprising:a data interface configured to receive: the encoded pump status signalfrom the pump controller, wherein the encoded pump status signalcomprises data corresponding to an availability of the ambulatorymedicament pump to deliver medicament to the subject; the encodedmedicament delivery signal from the pump controller, wherein the encodedmedicament delivery signal comprises data corresponding to an amount ofmedicament dosed to the subject; and a glucose level signal from aglucose sensor operatively coupled to the subject; a non-transitorymemory configured to store specific computer-executable instructions;and an electronic processor in communication with the non-transitorymemory and configured to execute the specific computer-executableinstructions to at least: receive, via the data interface, the glucoselevel signal from the glucose sensor; decode the glucose level signal toobtain a glucose level of the subject and an indication of a glucosetrend; calculate the dose control signal using a control algorithmconfigured to calculate regular correction boluses of glucose controlagent in response to at least the glucose level of the subject; receive,via the data interface, the encoded pump status signal from the pumpcontroller; select a pump controller decoding profile from a pluralityof pump controller decoding profiles, wherein each of the plurality ofpump controller decoding profiles corresponds to at least one of aplurality of pump controllers, wherein each pump controller decodingprofile is configured to decode at least the encoded pump status signaland the encoded medicament delivery signal, and wherein the selectedpump controller decoding profile corresponds to the pump controlleroperatively coupled to the ambulatory medicament pump; decode theencoded pump status signal and the encoded medicament delivery signalusing the selected pump controller decoding profile; select a pumpcontroller encoding profile from a plurality of pump controller encodingprofiles, wherein the selected pump controller encoding profilecorresponds to the pump controller operatively coupled to the ambulatorymedicament pump, wherein the pump controller encoding profile isconfigured to encode at least the dose control signal; based on theencoded pump status signal, determine that the ambulatory medicamentpump is available to deliver medicament to the subject and encode thedose control signal such that the pump controller can read the dosecontrol signal; and transmit the encoded dose control signal to the pumpcontroller of the ambulatory medicament pump, wherein the dose controlsignal commands the ambulatory medicament pump to administer glucosecontrol therapy via infusion of the glucose control agent into thesubject.

In a 211th example, a blood glucose control system configured to receivean encoded pump controller signal from a pump controller operativelycoupled to an ambulatory medicament pump and to route pass-through datanot used in a calculation of a dose control signal to a targetelectronic device, the blood glucose control system comprising: a datainterface configured to receive the encoded pump controller signal fromthe pump controller via a digital data connection and to receive theglucose level signal from the glucose sensor, the encoded pumpcontroller signal comprising: an encoded medicament delivery signalcorresponding to an amount of medicament dosed to the subject, andpass-through data comprising encoded pump controller alert data, whereinthe pass-through data is not used in the calculation of the dose controlsignal; a non-transitory memory configured to store specificcomputer-executable instructions; and an electronic processor incommunication with the non-transitory memory and configured to executethe specific computer-executable instructions to at least: receive, viathe data interface, the encoded pump controller signal from the pumpcontroller via the digital data connection and the glucose level signalfrom the glucose sensor; decode the encoded medicament delivery signaland the encoded pump controller alert data to obtain the amount ofmedicament dosed to the subject and the data not used in the calculationof the dose control signal; calculate the dose control signal using acontrol algorithm configured to calculate regular correction boluses ofglucose control agent in response to at least the glucose level of thesubject and the amount of medicament dosed to the subject; and route thedata not used in the calculation of the dose control signal to thetarget electronic device.

In a 212th example, the blood glucose control system of example 211,wherein the pass-through data comprises at least one of: an indicationthat a pump cartridge has a volume of medicament below a thresholdvolume; an indication that a supply of medicament is below a thresholdsupply; a charge level associated with a battery of the ambulatorymedicament pump; an indication that the glucose sensor has exceeded athreshold performance period; an indication to wirelessly couple a newglucose sensor with the ambulatory medicament pump; and an indicationthat a new pump cartridge has been installed in the ambulatorymedicament pump.

In a 213th example, the blood glucose control system of any of examples211-212, wherein the instructions, when executed by the hardwareprocessor, are configured to: determine that the pass-through data isunrelated to the calculation of the dose control signal; and based onthe determination that the pass-through data is not used in the dosecontrol signal, route the status alert to the target electronic device.

In a 214th example, the blood glucose control system of any of examples211-213, wherein the data interface is further configured to receiveencoded glucose sensor signal comprising second pass-throughcorresponding to second data not used in the calculation of the dosecontrol signal, and wherein the instructions, when executed by thehardware processor, are configured to: receive the encoded glucosesensor signal comprising the second pass-through data; decode theencoded glucose sensor signal to obtain the second data not used in thecalculation of the dose control signal; and route the second data notused in the calculation of the dose control signal to a second targetelectronic device.

In a 215th example, the blood glucose control system of any of examples211-214, wherein the data interface is further configured to receiveencoded source device signal comprising third pass-through correspondingto third data not used in the calculation of the dose control signal,and wherein the instructions, when executed by the hardware processor,are configured to: receive the encoded source device signal comprisingthe third pass-through data; and decode the encoded source device signalto obtain the third data not used in the calculation of the dose controlsignal; and route the third data not used in the calculation of the dosecontrol signal to a third target electronic device.

In a 216th example, an ambulatory medicament pump configured to enabletherapy change controls associated with a selected safe access level fora user of an ambulatory medicament pump configured to provide medicamenttherapy to a subject, the ambulatory medicament pump comprising: a pumpcontroller configured to receive a dose control signal configured tocause the ambulatory medicament pump to infuse a medicament from amedicament reservoir into the subject; a data interface configured tocommunicate with an electronic access device; a non-transitory memoryconfigured to store specific computer-executable instructions and aplurality of safe access level profiles, each safe access level profilespecifying therapy change controls associated with a safe access level,wherein the therapy change controls comprise a control for selecting amedicament therapy setting that affects administration of medicamenttherapy by the ambulatory medicament pump; and an electronic processorin communication with the non-transitory memory and configured toexecute the specific computer-executable instructions to at least:receive, via the data interface, an access signal from the electronicaccess device, wherein the access signal is configured to enable one ormore therapy change controls associated with the selected safe accesslevel; and in response to receiving the access signal, enable the one ormore therapy change controls associated with the selected safe accesslevel, wherein selecting a medicament therapy setting using the one ormore therapy change controls causes modification of a control parameterused by a control algorithm to affect the administration of medicamenttherapy by the ambulatory medicament pump.

In a 217th example, the ambulatory medicament pump of example 216,wherein the ambulatory medicament pump is configured to providemedicament therapy to control a blood glucose level in the subject.

In a 218th example, the computer-implemented method of example 217,wherein the medicament therapy comprises insulin therapy.

In a 219th example, the computer-implemented method of example 218,wherein the one or more therapy change controls comprise a control forselecting a type of the insulin therapy from a plurality of insulintherapy types.

In a 220th example, the ambulatory medicament pump of example 219,wherein the type of insulin therapy comprises U100 insulin therapy, U200insulin therapy, ultra-rapid insulin therapy, or fast-acting insulintherapy.

In a 221st example, the ambulatory medicament pump of any of examples216-220, wherein the control parameter is used by the control algorithmto account for an accumulation of insulin in the subject.

In a 222nd example, the ambulatory medicament pump of any of examples216-221, wherein the one or more therapy change controls associated withthe selected safe access level are enabled during a validity period.

In a 223rd example, the ambulatory medicament pump of example 222,wherein the validity period is one hour, one day, or one week.

In a 224th example, the ambulatory medicament pump of any of examples222-223, wherein the validity period expires when the subject associatedwith the ambulatory medicament pump changes.

In a 225th example, the ambulatory medicament pump of any of examples222-224, wherein the validity period is modified from a first period toa second period in response to a user interaction with a user interfaceof the ambulatory medicament pump.

In a 226th example, the ambulatory medicament pump of any of examples216-225, wherein the data interface is configured to communicate withthe electronic access device via a wired or a wireless communicationconnection.

In a 227th example, the ambulatory medicament pump of example 226,wherein the wireless communication connection comprises: a Long-TermEvolution wireless connection, a Wi-Fi network connection, a 5Gcommunication network connection, a wide area network connection, anear-field communication network connection, or a short-range wirelessconnection.

In a 228th example, the ambulatory medicament pump of any of examples216-227, wherein the electronic access device comprises a personalcomputer, a mobile phone, a dedicated electronic access device, a cloudserver, or a passcode server.

In a 229th example, the ambulatory medicament pump of any of examples216-228, wherein the electronic access device comprises an electronicdevice associated with a healthcare provider or a trainer of the user orthe subject.

In a 230th example, the ambulatory medicament pump of any of examples216-229, wherein the selected safe access level is associated with atherapy history of the subject, or a training level of the subject orthe user.

In a 231st example, the ambulatory medicament pump of any of examples216-230, wherein the selected safe access level is associated with amedicament prescription of the subject.

In a 232nd example, the ambulatory medicament pump of any of examples216-231, wherein the electronic processor is further configured toenable the one or more therapy change controls associated with theselected safe access level by displaying therapy change control elementson a user interface wherein the therapy change control elements enablemodification of control parameter values corresponding to the one ormore therapy change controls.

In a 233rd example, the ambulatory medicament pump of any of examples216-232, wherein the electronic processor is further configured toenable the one or more therapy change controls associated with theselected safe access level by unlocking therapy change control elementsin a menu displayed on a user interface wherein the therapy changecontrol elements enable modification of control parameter valuescorresponding to the one or more therapy change controls.

In a 234th example, the ambulatory medicament pump of any of examples216-233, wherein the electronic processor is further configured toexecute the specific computer-executable instructions to at least:receive, responsive to a user interaction with a user interface, arequest to restore the control parameter to a previous value; andrestore the control parameter to the previous value.

In a 235th example, the ambulatory medicament pump of any of examples216-234, wherein the access signal comprises a time-based passcodeassociated with the safe access level, wherein the time-based passcodeis configured to expire after a validity period, and wherein in responseto receiving the access signal, the electronic processor is furtherconfigured to execute the specific computer-executable instructions toat least: receive a user passcode in response to user interaction with apasscode entry interface; determine that the user passcode matches thetime-based passcode and that the user passcode is received during thevalidity period; and in response to determining that the user passcodematches the time-based passcode and that the passcode attempt isreceived during the validity period, enable the therapy change controlsassociated with the safe access level.

In a 236th example, the ambulatory medicament pump of any of examples216-235, wherein the user is the subject receiving medicament therapyfrom the ambulatory medicament pump.

In a 237th example, a computer-implemented method of enabling therapychange controls associated with a selected safe access level for a userof an ambulatory medicament pump configured to provide medicamenttherapy to a subject, wherein the medicament therapy comprises infusinga medicament to the subject, the computer-implemented method comprising:by an electronic processor of the ambulatory medicament pump, whereinthe electronic processor is configured to execute specificcomputer-executable instructions stored in a non-transitory memory incommunication with the electronic processor, receiving, via a digitaldata interface, an access signal from the electronic access device,wherein the access signal is configured to enable one or more therapychange controls associated with the selected safe access level, whereinthe selected safe access level is associated with at least one of aplurality of safe access level profiles, each safe access level profilespecifying therapy change controls associated with a safe access level,and wherein the one or more therapy change controls affectadministration of medicament therapy by the ambulatory medicament pump;and in response to receiving the access signal, enabling the one or moretherapy change controls associated with the safe access level, whereinselecting a medicament therapy setting using the one or more therapychange controls causes modification of a control parameter used by acontrol algorithm to affect administration of the medicament therapy bythe ambulatory medicament pump.

In a 238th example, the computer-implemented method of example 237,wherein the ambulatory medicament pump is configured to providemedicament therapy to control a glucose level in the subject.

In a 239th example, the computer-implemented method of example 238,wherein the medicament therapy comprises insulin therapy.

In a 240th example, the computer-implemented method of example 239,wherein the one or more therapy change controls comprise a control forselecting a type of the insulin therapy from a plurality of insulintherapy types.

In a 241st example, the ambulatory medicament pump of example 240,wherein the type of insulin therapy comprises U100 insulin therapy, U200insulin therapy, ultra-rapid insulin therapy, or fast-acting insulintherapy.

In a 242nd example, the computer-implemented method of any of examples237-241, wherein the control parameter is used by the control algorithmto account for an accumulation of insulin in the subject.

In a 243rd example, the computer-implemented method of any of examples237-242, wherein the one or more therapy change controls associated withthe selected safe access level are enabled during a validity period.

In a 244th example, the computer-implemented method of any of examples243-243, wherein the validity period is one hour, one day, or one week.

In a 245th example, the computer-implemented method of any of examples243-244, wherein the validity period expires when the subject associatedwith the ambulatory medicament pump changes.

In a 246th example, the computer-implemented method of any of examples242-245, wherein the validity period is modified from a first period toa second period in response to a user interaction with user interface ofthe ambulatory medicament pump.

In a 247th example, the computer-implemented method of any of examples237-246, wherein the data interface is configured to communicate withthe electronic access device via a wired or a wireless communicationconnection.

In a 248th example, the computer-implemented method of example 247,wherein the wireless communication connection comprises a Long-TermEvolution wireless connection, a Wi-Fi network connection, a 5Gcommunication network connection, a wide area network connection, anear-field communication network connection, or a short-range wirelessconnection.

In a 249th example, the computer-implemented method of any of examples237-248, wherein the electronic access device comprises a computer, amobile phone, a cloud server, or a dedicated electronic access device.

In a 250th example, the computer-implemented method of any of examples237-249, wherein the electronic access device comprises an electronicdevice that is associated with a healthcare provider or a trainer of thesubject.

In a 251st example, the computer-implemented method of any of examples237-250, wherein the safe access level is associated with a therapyhistory or a training level of the subject.

In a 252nd example, the computer-implemented method of any of examples237-251, wherein the safe access level is selected based at least inpart on a medicament prescription of the subject.

In a 253rd example, the computer-implemented method of any of examples237-252, wherein enabling the one or more therapy change controlsassociated with the selected safe access level comprises displayingtherapy change control elements on a user interface, and wherein thetherapy change control elements enable modification of control parametervalues corresponding to the therapy change controls.

In a 254th example, the computer-implemented method of any of examples237-253, wherein enabling the one or more therapy change controlsassociated with the selected safe access level comprises unlockingtherapy change control elements in a menu displayed on a user interface,and wherein the therapy change control elements enable modification ofcontrol parameter values corresponding to the therapy change controls.

In a 255th example, the computer-implemented method of any of examples237-254, further comprising: receiving, responsive to user interactionwith a user interface, a request to restore the control parameter to aprevious value; and restoring the control parameter to the previousvalue.

In a 256th example, the computer-implemented method of any of examples237-255, wherein the access signal corresponds to a time-based passcodeassociated with the safe access level, wherein the time-based passcodeis configured to expire after a validity period, and wherein thecomputer-implemented method further comprises: receiving a user passcodein response to user interaction with a passcode entry interface;determining that the user passcode matches the time-based passcode andthat the user passcode is received during the validity period; and inresponse to determining that the user passcode matches the time-basedpasscode and that the passcode attempt is received during the validityperiod, enabling the therapy change controls associated with the safeaccess level.

In a 257th example, the computer-implemented method of any of examples237-256, wherein the user is the subject receiving medicament therapyfrom the ambulatory medicament pump.

In a 258th example, a computer-implemented method of managing access totherapy change controls of an ambulatory medicament pump configured toprovide medicament therapy to a subject, the computer-implemented methodcomprising: by an electronic processor of an electronic evaluationdevice, wherein the electronic processor is configured to executespecific computer-executable instructions stored in the electronicevaluation device to determine a safe access level from a plurality ofsafe access levels: receiving, from an electronic device incommunication with the electronic evaluation device, evaluation dataassociated with the subject, wherein the evaluation data comprisestherapy data corresponding to glycemic control of the subject by theambulatory medicament pump; determining a safe access level for a userof the ambulatory medicament pump based at least in part on theevaluation data, wherein the safe access level is associated with aplurality of therapy change controls of the ambulatory medicament pump,and wherein the plurality of therapy change controls comprise a controlfor selecting a medicament therapy setting that affects administrationof medicament therapy by the ambulatory medicament pump; determining,based at least in part on the evaluation data, a validity period duringwhich the plurality of change controls are enabled; generating an accesssignal that, when received by the ambulatory medicament pump, isconfigured to cause the plurality of therapy change controls to beenabled during the validity period; and transmitting the access signalto the ambulatory medicament pump via a data connection.

In a 259th example, the computer-implemented method of example 258,wherein the electronic evaluation device is a personal electronic deviceof the user or subject, an electronic device used by a healthcareprovider or a trainer, or a cloud server.

In a 260th example, the computer-implemented method of any of examples258-259, wherein the electronic device is the ambulatory medicamentpump.

In a 261st example, the computer-implemented method of any of examples258-260, wherein the electronic device is an electronic device used by aphysician or a trainer or a personal electronic device of a physician ora trainer.

In a 262nd example, the computer-implemented method of any of examples258-261, wherein the data connection is a wired or wireless connection.

In a 263rd example, the computer-implemented method of example 262,wherein the wireless connection comprises a Long-Term Evolution networkconnection, a Wi-Fi network connection, a 5G communication networkconnection, a wide area network connection, a near-field communicationnetwork connection, or a short-range wireless network connection.

In a 264th example, the computer-implemented method of any of examples258-263, wherein the validity period comprises one hour, one day, or oneweek.

In a 265th example, the computer-implemented method of any of examples258-264, wherein the ambulatory medicament pump is configured to providemedicament therapy to control a glucose level in the subject.

In a 266th example, the computer-implemented method of example 265,wherein the medicament comprises insulin.

In a 267th example, the computer-implemented method of example 266,wherein the plurality of therapy change controls comprise a control forselecting a type of insulin.

In a 268th example, the computer-implemented method of example 267,wherein at least one of the one or more control parameters is used bythe control algorithm to account for an accumulation of insulin in thesubject.

In a 269th example, the computer-implemented method of any of examples267-268, wherein the type of insulin comprises U100 insulin, U200insulin, ultra-rapid insulin, or fast-acting insulin.

In a 270th example, the computer-implemented method of any of examples258-269, wherein the safe access level is selected based at least inpart on a medicament prescription of the subject.

In a 271st example, the computer-implemented method of any of examples258-270, wherein the validity period expires when the subject associatedwith the ambulatory medicament pump changes.

In a 272nd example, the computer-implemented method of any of examples258-271, wherein the validity period is extendable or renewable inresponse to receiving an extension or renewal request.

In a 273rd example, the computer-implemented method of any of examples258-272, wherein the user is the subject receiving medicament therapyfrom the ambulatory medicament pump.

In a 274th example, the computer-implemented method of any of examples258-273, wherein generating the access signal comprises generating atime-based passcode associated with the safe access level, and whereinreceipt of a user passcode that matches the time-based passcode, by theambulatory medicament pump from the user, causes the ambulatorymedicament pump to enable the therapy change controls associated withthe safe access level.

In a 275th example, a computer-implemented method of enabling therapychange controls associated with a safe access level for a user of anambulatory medicament pump configured to provide medicament therapy to asubject wherein the medicament therapy comprises infusing a medicamentinto the subject, the computer-implemented method comprising: by anelectronic processor of the ambulatory medicament pump, wherein theelectronic processor is configured to execute specificcomputer-executable instructions stored in a non-transitory memoryconnected to the electronic processor: receiving, via a therapy changecontrol request interface, a request to access therapy change controlsassociated with the safe access level, wherein the safe access level isassociated with at least one of a plurality of safe access levelprofiles, each safe access level profile specifying one or more therapychange controls associated with the selected safe access level, andwherein the one or more therapy change controls affect administration ofmedicament therapy by the ambulatory medicament pump; and in response toreceiving the request to access the therapy change controls associatedwith the safe access level: establishing a data connection with anelectronic passcode device; sending a passcode request to an electronicpasscode device wherein the passcode request comprises a deviceidentifier, wherein the device identifier is usable to uniquely identifythe ambulatory medicament pump; receiving a user passcode attempt viauser interaction with a passcode entry interface, wherein the userpasscode is generated by the electronic passcode device upon receivingthe passcode request; determining that the passcode attempt matches thedevice passcode; and in response to determining that the passcodeattempt matches a device passcode, enabling the one or more therapychange controls associated with the safe level access.

In a 276th example, the computer-implemented method of example 275,wherein the user of the ambulatory medicament pump is the subjectreceiving medicament therapy provided by the ambulatory medicament pump.

In a 277th example, the computer-implemented method of any of examples275-276, wherein the ambulatory medicament pump is configured to providemedicament therapy to control a glucose level in the subject.

In a 278th example, the computer-implemented method of example 277,wherein the medicament therapy comprises insulin therapy.

In a 279th example, the computer-implemented method of example 278,wherein the one or more therapy change controls comprise a control forselecting a type of the insulin therapy from a plurality of insulintherapy types.

In a 280th example, the ambulatory medicament pump of example 279,wherein the type of the insulin therapy comprises U100 insulin therapy,U200 insulin therapy, ultra-rapid insulin therapy, or fast-actinginsulin therapy.

In a 281st example, the computer-implemented method of any of examples278-280, wherein the control parameter is used by the control algorithmto account for an accumulation of insulin in the subject.

In a 282nd example, the computer-implemented method of any of examples275-281, further comprising generating the device passcode using ashared passcode algorithm, wherein the shared passcode algorithmcomprises the same passcode algorithm used by the electronic passcodedevice to generate the user passcode.

In a 283rd example, the computer-implemented method of any of examples275-282, further comprising: by an electronic processor of theelectronic passcode device, wherein the electronic processor of theelectronic passcode device is configured to execute specificcomputer-executable passcode generation instructions stored in a secondnon-transitory memory connected to the electronic processor of theelectronic passcode device: receiving the device identifier; verifyingeligibility of the user for the safe access level; and in response toverifying eligibility of the user for the safe access level, generatingthe user passcode using a shared passcode algorithm and the deviceidentifier.

In a 284th example, the computer-implemented method of example 283,wherein said verifying eligibility of the user for the safe access levelcomprises receiving eligibility data from an electronic evaluationdevice.

In a 285th example, the computer-implemented method of example 284,wherein said receiving eligibility data from an electronic evaluationdevice comprises receiving a validity period, and wherein the userpasscode is a time-based user passcode usable for enabling the one ormore therapy change controls associated with the safe level accessduring the validity period.

In a 286th example, the computer-implemented method of example 285,wherein said determining that the passcode attempt matches the devicepasscode comprises determining that the passcode is received during thevalidity period.

In a 287th example, the computer-implemented method of any of examples285-286, wherein said enabling the therapy change controls comprisesenabling the one or more therapy change controls during the validityperiod.

In a 288th example, the computer-implemented method of example 287,wherein the validity period is one hour, one day or one week.

In a 289th example, the computer-implemented method of any of examples285-288, further comprising extending or renewing the validity period inresponse to an extension or renewal request to extend or renew access tothe one or more therapy change controls associated with the safe levelaccess.

In a 290th example, the computer-implemented method of any of examples275-289, wherein the data connection is a wired or wireless connection.

In a 291st example, the computer-implemented method of example 290,wherein the wireless connection comprises a Long-Term Evolutionconnection, a Wi-Fi network connection, a 5G communication networkconnection, a wide area network connection, a near-field communicationnetwork connection, or a short-range wireless connection.

In a 292nd example, the computer-implemented method of any of examples275-291, wherein the user passcode is output to the user by theelectronic passcode device via a text message.

In a 293rd example, the computer-implemented method of any of examples284-292, wherein the electronic evaluation device is the electronicdevice of a healthcare provider or a trainer.

In a 294th example, the computer-implemented method of any of examples275-293, wherein the device identifier comprises an IP address, a MACaddress, or a serial number.

In a 295th example, a glucose level control system configured to modifyor enable modification of a control algorithm of the glucose levelcontrol system based on a safe access level for a user of an ambulatorymedicament pump configured to provide medicament therapy to a subject,the glucose level control system comprising: a non-transitory memoryconfigured to store specific computer-executable instructions; and ahardware processor in communication with the non-transitory memory andconfigured to execute the specific computer-executable instructions toat least: receive a first access code via an access code entryinterface, wherein the first access code comprises first safe accesslevel data and a first unique identifier; validate the first access codeto determine whether to enable a second glucose level therapy controlconfiguration, wherein the second glucose level therapy controlconfiguration is different from a first glucose level therapy controlconfiguration of the glucose level control system; and enable the secondglucose level therapy control configuration responsive to validating thefirst access code, wherein the second glucose level therapy controlconfiguration modifies or enables modification of execution of a controlalgorithm that generates a dose control signal to cause the ambulatorymedicament pump to administer a quantity of medicament from a medicamentreservoir into the subject.

In a 296th example, the glucose level control system of example 295,wherein the first access code comprises an encrypted access code, andwherein the hardware processor is configured to validate the firstaccess code by at least: decrypting the encrypted access code to accessthe first unique identifier and the first safe access level data; andverifying that the first unique identifier matches a second uniqueidentifier corresponding to the glucose level control system.

In a 297th example, the glucose level control system of example 296,wherein the first access code further comprises a first time-basedvalue, and wherein the hardware processor is further configured tovalidate the first access code by at least determining whether the firsttime-based value is valid or expired.

In a 298th example, the glucose level control system of example 297,wherein the first time-based value corresponds to a period of timeduring which the first access code is valid.

In a 299th example, the glucose level control system of any of examples297-298, wherein the hardware processor is further configured todetermine whether the first time-based value is valid or expired by atleast comparing the first time-based value to a second time-based valuegenerated at the glucose level control system.

In a 300th example, the glucose level control system of example 299,wherein the first time based-value and the second time based-value aregenerated based on a seed value, the seed value being the same valueused to generate both the first time based-value and the second timebased-value, and wherein the first time based-value and the second timebased-value are scheduled to expire at the same time.

In a 301st example, the glucose level control system of any of examples296-300, wherein the second unique identifier is stored in thenon-transitory memory.

In a 302nd example, the glucose level control system of any of examples295-301, wherein the hardware processor is further configured to executethe specific computer-executable instructions to at least receive anindication of second safe access level data.

In a 303rd example, the glucose level control system of example 302,wherein the first access code is a first hashed value, and wherein thehardware processor is configured to validate the first access code by atleast: hashing the second safe access level data and a second uniqueidentifier corresponding to the glucose level control system to obtain asecond hashed value; and comparing the first hashed value to the secondhashed value.

In a 304th example, the glucose level control system of example 303,wherein the hardware processor is further configured to execute thespecific computer-executable instructions to at least determine that thefirst access code is valid when the first hashed value matches thesecond hashed value.

In a 305th example, the glucose level control system of any of examples303-304, wherein the first access code further comprises a first timebased-value, and wherein a second time based-value is hashed with thesecond safe access level data and the second unique identifier to obtainthe second hashed value.

In a 306th example, the glucose level control system of example 305,wherein the first time based-value and the second time based-value aregenerated based on a seed value, the seed value being the same valueused to generate both the first time based-value and the second timebased-value, and wherein the first time based-value and the second timebased-value are scheduled to expire at the same time.

In a 307th example, the glucose level control system of any of examples305-306, wherein the first time-based value corresponds to a period oftime during which the first access code is valid.

In a 308th example, the glucose level control system of any of examples303-307, wherein the second unique identifier is stored in thenon-transitory memory.

In a 309th example, the glucose level control system of any of examples295-308, wherein the first safe access level data identifies one or moreof: a new therapy control interface, a control parameter to include in atherapy control interface, the control parameter to enable in thetherapy control interface, a control parameter value for the controlparameter, or a new control algorithm functionality for the controlparameter.

In a 310th example, the glucose level control system of any of examples295-309, wherein the access code entry interface comprises a userinterface that enables the user to enter the first access code.

In a 311th example, the glucose level control system of any of examples295-310, wherein the access code entry interface comprises a wired orwireless network connection to a computing device configured to transmitthe first access code to the glucose level control system.

In a 312th example, the glucose level control system of any of examples295-311, wherein the second glucose level therapy control configurationenables access to a control parameter, and wherein the control parameteraffects glycemic control of the subject.

In a 313th example, the glucose level control system of any of examples295-312, wherein the hardware processor is further configured to enablethe second glucose level therapy control configuration by permitting theuser to access a new therapy control interface that enables the user tomodify one or more control parameters used by the control algorithm.

In a 314th example, the glucose level control system of example 313,wherein the new therapy control interface is not accessible by the userprior to the first access code being validated.

In a 315th example, the glucose level control system of any of examples295-314, wherein the hardware processor is further configured to executethe specific computer-executable instructions to at least disable afeature of the glucose level control system associated with the secondglucose level therapy control configuration.

In a 316th example, the glucose level control system of example 315,wherein the hardware processor is further configured to disable thefeature of the glucose level control system associated with the secondglucose level therapy control configuration responsive to validating asecond access code.

In a 317th example, the glucose level control system of any of examples315-316, wherein the hardware processor is further configured to disablethe feature of the glucose level control system associated with thesecond glucose level therapy control configuration by reverting theglucose level control system to the first glucose level therapy controlconfiguration.

In a 318th example, the glucose level control system of any of examples295-317, wherein the second glucose level therapy control configurationis associated with an expiration value.

In a 319th example, the glucose level control system of example 318,wherein the glucose level control system automatically reverts to thefirst glucose level therapy control configuration upon the expirationvalue being satisfied.

In a 320th example, the glucose level control system of any of examples318-319, wherein the expiration value comprises one or more of a time, adate, or a number of administrations of medicament.

In a 321st example, the glucose level control system of any of examples295-320, wherein the first access code further comprises anerror-detection code.

In a 322nd example, the glucose level control system of example 321,wherein the hardware processor is further configured to execute thespecific computer-executable instructions to at least use theerror-detection code to confirm that the first access code is error freeor can be recovered from a detected error.

In a 323rd example, the glucose level control system of any of examples321-322, wherein the error-detection code comprises a checksum, a cyclicredundancy check, a hash value, an error correction code, or a paritybit.

In a 324th example, the glucose level control system of any of examples295-323, wherein enabling the second glucose level therapy controlconfiguration comprises downloading an update to the control algorithmof the glucose level control system and/or downloading an update to thespecific computer-executable instructions from a computing systemseparate from the glucose level control system.

In a 325th example, a computer-implemented method of modifying orenabling modification of execution of a control algorithm of a glucoselevel control system based on a safe access level for a user of anambulatory medicament pump configured to provide medicament therapy to asubject and controlled by the glucose level control system, thecomputer-implemented method comprising: by a hardware processor of theglucose level control system, receiving a first access code via anaccess code entry interface, wherein the first access code comprisesfirst safe access level data and a first unique identifier; validatingthe first access code to determine whether to enable a second glucoselevel therapy control configuration, wherein the second glucose leveltherapy control configuration is different from a first glucose leveltherapy control configuration of the glucose level control system; andenabling the second glucose level therapy control configurationresponsive to validating the first access code, wherein the secondglucose level therapy control configuration modifies or enablesmodification of execution of a control algorithm that generates a dosecontrol signal to cause the ambulatory medicament pump to administer aquantity of medicament from a medicament reservoir into the subject.

In a 326th example, the computer-implemented method of example 325,wherein the first access code comprises an encrypted access code, andwherein said validating the first access code comprises: decrypting theencrypted access code to access the first unique identifier and thefirst safe access level data; and verifying that the first uniqueidentifier matches a second unique identifier corresponding to theglucose level control system.

In a 327th example, the computer-implemented method of example 326,wherein the first access code further comprises a first time-basedvalue, and wherein said validating the first access code furthercomprises determining whether the first time-based value is valid orexpired.

In a 328th example, the computer-implemented method of example 327,wherein the first time-based value corresponds to a period of timeduring which the first access code is valid.

In a 329th example, the computer-implemented method of any of examples327-328, wherein said determining whether the first time-based value isvalid or expired comprises comparing the first time-based value to asecond time-based value generated at the glucose level control system.

In a 330th example, the computer-implemented method of example 329,wherein the first time based-value and the second time based-value aregenerated based on a seed value, the seed value being the same valueused to generate both the first time based-value and the second timebased-value, and wherein the first time based-value and the second timebased-value are scheduled to expire at the same time.

In a 331st example, the computer-implemented method of any of examples326-330, wherein the second unique identifier is stored at the glucoselevel control system.

In a 332nd example, the computer-implemented method of any of examples325-331, further comprising receiving an indication of second safeaccess level data.

In a 333rd example, the computer-implemented method of example 332,wherein the first access code is a first hashed value, and wherein saidvalidating the first access code comprises: hashing the second safeaccess level data and a second unique identifier corresponding to theglucose level control system to obtain a second hashed value; andcomparing the first hashed value to the second hashed value.

In a 334th example, the computer-implemented method of example 333,further comprising determining that the first access code is valid whenthe first hashed value matches the second hashed value.

In a 335th example, the computer-implemented method of any of examples333-334, wherein the first access code further comprises a first timebased-value, and wherein a second time based-value is hashed with thesecond safe access level data and the second unique identifier to obtainthe second hashed value.

In a 336th example, the computer-implemented method of example 335,wherein the first time based-value and the second time based-value aregenerated based on a seed value, the seed value being the same valueused to generate both the first time based-value and the second timebased-value, and wherein the first time based-value and the second timebased-value are scheduled to expire at the same time.

In a 337th example, the computer-implemented method of any of examples335-336, wherein the first time-based value corresponds to a period oftime during which the first access code is valid.

In a 338th example, the computer-implemented method of any of examples333-337, wherein the second unique identifier is stored at the glucoselevel control system.

In a 339th example, the computer-implemented method of any of examples325-338, wherein the first safe access level data identifies one or moreof: a new therapy control interface, a control parameter to include in atherapy control interface, the control parameter to enable in thetherapy control interface, a control parameter value for the controlparameter, or a new control algorithm functionality for the controlparameter.

In a 340th example, the computer-implemented method of any of examples325-339, wherein the access code entry interface comprises a userinterface that enables the user to enter the first access code.

In a 341st example, the computer-implemented method of any of examples325-340, wherein the access code entry interface comprises a wired orwireless network connection to a computing device configured to transmitthe first access code to the glucose level control system.

In a 342nd example, the computer-implemented method of any of examples325-341, wherein the second glucose level therapy control configurationenables access to a control parameter, and wherein the control parameteraffects glycemic control of the subject.

In a 343rd example, the computer-implemented method of any of examples325-342, wherein said enabling the second glucose level therapy controlconfiguration comprises permitting the user to access a new therapycontrol interface that enables the user to modify one or more controlparameters used by the control algorithm.

In a 344th example, the computer-implemented method of example 343,wherein the new therapy control interface is not accessible by the userprior to the first access code being validated.

In a 345th example, the computer-implemented method of any of examples325-344, further comprising disabling a feature of the glucose levelcontrol system associated with the second glucose level therapy controlconfiguration.

In a 346th example, the computer-implemented method of example 345,further comprising validating a second access code, wherein the featureof the glucose level control system associated with the second glucoselevel therapy control configuration is disabled responsive to the secondaccess code being validated.

In a 347th example, the computer-implemented method of any of examples345-346, wherein disabling the feature of the glucose level controlsystem associated with the second glucose level therapy controlconfiguration comprises reverting the glucose level control system tothe first glucose level therapy control configuration.

In a 348th example, the computer-implemented method of any of examples325-347, wherein the second glucose level therapy control configurationis associated with an expiration value.

In a 349th example, the computer-implemented method of example 348,further comprising automatically reverting to the first glucose leveltherapy control configuration upon the expiration value being satisfied.

In a 350th example, the computer-implemented method of any of examples348-349, wherein the expiration value comprises one or more of a time, adate, or a number of administrations of medicament.

In a 351st example, the computer-implemented method of any of examples325-350, wherein the first access code further comprises anerror-detection code.

In a 352nd example, the computer-implemented method of example 351,further comprising confirm that the first access code is error free orcan be recovered from a detected error based at least in part on theerror-detection code.

In a 353rd example, the computer-implemented method of any of examples351-352, wherein the error-detection code comprises a checksum, a cyclicredundancy check, a hash value, an error correction code, or a paritybit.

In a 354th example, the computer-implemented method of any of examples325-353, wherein enabling the second glucose level therapy controlconfiguration comprises downloading an update to the control algorithmof the glucose level control system from a computing system separatefrom the glucose level control system.

In a 355th example, an electronic configuration device configured tomodify or enable modification, at a glucose level control system, of acontrol algorithm based on a selected safe access level for a user of anambulatory medicament pump controlled by the glucose level controlsystem, the electronic configuration device comprising: a non-transitorymemory configured to store specific computer-executable instructions;and a hardware processor in communication with the non-transitory memoryand configured to execute the specific computer-executable instructionsto at least: receive an indication to modify a glucose level therapycontrol configuration of the glucose level control system to a secondglucose level therapy control configuration that differs from a firstglucose level therapy control configuration of the glucose level controlsystem, wherein modifying the glucose level therapy controlconfiguration modifies or enables modification of execution of thecontrol algorithm that generates a dose control signal to cause theambulatory medicament pump to administer a quantity of medicament from amedicament reservoir into a subject; receive a first unique identifierassociated with the glucose level control system; validate the user'scapability to safely use the glucose level control system with thesecond glucose level therapy control configuration; responsive tovalidating the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration,generate a first access code comprising safe access level data and thefirst unique identifier, wherein the safe access level data correspondsto the second glucose level therapy control configuration; and outputthe first access code, wherein the first access code is useable to causethe glucose level therapy control configuration of the glucose levelcontrol system to be modified from the first glucose level therapycontrol configuration to the second glucose level therapy controlconfiguration.

In a 356th example, the electronic configuration device of example 355,wherein the hardware processor is further configured to execute thespecific computer-executable instructions to at least encrypt the firstaccess code to obtain an encrypted access code, and wherein outputtingthe first access code comprises outputting the encrypted access code.

In a 357th example, the electronic configuration device of any ofexamples 355-356, wherein the hardware processor is further configuredto execute the specific computer-executable instructions to at leasthash the first access code to obtain a hashed access code, and whereinoutputting the first access code comprises outputting the hashed accesscode.

In a 358th example, the electronic configuration device of any ofexamples 355-357, wherein the hardware processor is further configuredto output the first access code on a display of the electronic passcodedevice.

In a 359th example, the electronic configuration device of any ofexamples 355-358, wherein the hardware processor is further configuredto output the first access code by transmitting the first access codeover a wired or wireless network connection to the glucose level controlsystem.

In a 360th example, the electronic configuration device of any ofexamples 355-359, wherein the hardware processor is further configuredto receive the indication to modify the glucose level therapy controlconfiguration of the glucose level control system to the second glucoselevel therapy control configuration in response to a first userinteracting with a user interface of the electronic passcode device.

In a 361st example, the electronic configuration device of example 360,wherein the hardware processor is further configured to output the firstaccess code by transmitting the first access code over a wired orwireless network connection to a computing device of a second userenabling the computing device to: output the first access code on a userinterface of the computing device; or to communicate the first accesscode to the glucose level control system.

In a 362nd example, the electronic configuration device of any ofexamples 355-361, wherein the hardware processor is further configuredto execute the specific computer-executable instructions to at leastgenerate a first time-based value.

In a 363rd example, the electronic configuration device of example 362,wherein the hardware processor is further configured to include thefirst time-based value as part of the first access code when generatingthe first access code.

In a 364th example, the electronic configuration device of any ofexamples 362-363, wherein the first time-based value corresponds to aperiod of time during which the first access code is valid.

In a 365th example, the electronic configuration device of any ofexamples 362-364, wherein the first time based-value is generated basedon a seed value, the seed value being the same value used to generate asecond time based-value at the glucose level control system.

In a 366th example, the electronic configuration device of example 365,wherein the first time based-value and the second time based-value arescheduled to expire at the same time.

In a 367th example, the electronic configuration device of any ofexamples 355-366, wherein the safe access level data identifies one ormore of: a new therapy control interface, a control parameter to includein a therapy control interface, the control parameter to enable in thetherapy control interface, a control parameter value for the controlparameter, or a new control algorithm functionality for the controlparameter.

In a 368th example, the electronic configuration device of any ofexamples 355-367, wherein the hardware processor is configured tovalidate the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration by atleast accessing training data associated with the user and confirmingthat the training data satisfies a training threshold.

In a 369th example, the electronic configuration device of any ofexamples 355-368, wherein the hardware processor is configured tovalidate the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration by atleast accessing a prescription associated with the subject, theprescription corresponding to the safe access level data.

In a 370th example, the electronic configuration device of any ofexamples 355-369, wherein the hardware processor is configured tovalidate the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration by atleast: outputting a set of queries for display to the user, wherein theset of queries correspond to one or more use cases of the glucose levelcontrol system; receiving a set of responses to the set of queries;evaluating the set of responses to obtain an evaluation score; anddetermining based at least in part on the evaluation score whether theuser is capable of safely using the glucose level control system withthe second glucose level therapy control.

In a 371st example, the electronic configuration device of any ofexamples 355-370, wherein the hardware processor is configured tovalidate the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration by atleast evaluating use of the glucose level control system over anevaluation time period.

In a 372nd example, a computer-implemented method of modifying orenabling modification, at a glucose level control system, of a controlalgorithm based on a selected safe access level for a user of anambulatory medicament pump controlled by the glucose level controlsystem, the computer-implemented method comprising: by a hardwareprocessor of an electronic configuration device separate from theglucose level control system, receiving an indication to modify aglucose level therapy control configuration of the glucose level controlsystem to a second glucose level therapy control configuration thatdiffers from a first glucose level therapy control configuration of theglucose level control system, wherein modifying the glucose leveltherapy control configuration modifies or enables modification ofexecution of the control algorithm that generates a dose control signalto cause the ambulatory medicament pump to administer a quantity ofmedicament from a medicament reservoir into a subject; receiving a firstunique identifier associated with the glucose level control system;validating the user's capability to safely use the glucose level controlsystem with the second glucose level therapy control configuration;responsive to validating the user's capability to safely use the glucoselevel control system with the second glucose level therapy controlconfiguration, generating a first access code comprising safe accesslevel data and the first unique identifier, wherein the safe accesslevel data corresponds to the second glucose level therapy controlconfiguration; and outputting the first access code, wherein the firstaccess code is useable to cause the glucose level therapy controlconfiguration of the glucose level control system to by modified fromthe first glucose level therapy control configuration to the secondglucose level therapy control configuration.

In a 373rd example, the computer-implemented method of example 372,further comprising encrypting the first access code to obtain anencrypted access code, wherein outputting the first access codecomprises outputting the encrypted access code.

In a 374th example, the computer-implemented method of any of examples372-373, further comprising hashing the first access code to obtain ahashed access code, wherein outputting the first access code comprisesoutputting the hashed access code.

In a 375th example, the computer-implemented method of any of examples372-374, wherein outputting the first access code comprises outputtingthe first access code on a display of the electronic passcode device.

In a 376th example, the computer-implemented method of any of examples372-375, wherein outputting the first access code comprises transmittingthe first access code over a wired or wireless network connection to theglucose level control system.

In a 377th example, the computer-implemented method of any of examples372-376, wherein said receiving the indication to modify the glucoselevel therapy control configuration of the glucose level control systemto the second glucose level therapy control configuration occurs inresponse to a first user interacting with a user interface of theelectronic passcode device.

In a 378th example, the computer-implemented method of example 377,wherein said outputting the first access code comprises transmitting thefirst access code over a wired or wireless network connection to acomputing device of a second user enabling the computing device to:output the first access code on a user interface of the computingdevice; or to communicate the first access code to the glucose levelcontrol system.

In a 379th example, the computer-implemented method of any of examples372-378, further comprising generating a first time-based value.

In a 380th example, the computer-implemented method of example 379,wherein said generating the first access code includes incorporating thefirst time-based value as part of the first access code.

In a 381st example, the computer-implemented method of any of examples379-380, wherein the first time-based value corresponds to a period oftime during which the first access code is valid.

In a 382nd example, the computer-implemented method of any of examples379-381, wherein the first time based-value is generated based on a seedvalue, the seed value being the same value used to generate a secondtime based-value at the glucose level control system.

In a 383rd example, the computer-implemented method of example 382,wherein the first time based-value and the second time based-value arescheduled to expire at the same time.

In a 384th example, the computer-implemented method of any of examples372-383, wherein the safe access level data identifies one or more of: anew therapy control interface, a control parameter to include in atherapy control interface, the control parameter to enable in thetherapy control interface, a control parameter value for the controlparameter, or a new control algorithm functionality for the controlparameter.

In a 385th example, the computer-implemented method of any of examples372-384, wherein said validating the user's capability to safely use theglucose level control system with the second glucose level therapycontrol configuration comprises accessing training data associated withthe user and confirming that the training data satisfies a trainingthreshold.

In a 386th example, the computer-implemented method of any of examples372-385, wherein said validating the user's capability to safely use theglucose level control system with the second glucose level therapycontrol configuration comprises accessing a prescription associated withthe subject, the prescription corresponding to the safe access leveldata.

In a 387th example, the computer-implemented method of any of examples372-386, wherein said validating the user's capability to safely use theglucose level control system with the second glucose level therapycontrol configuration comprises: outputting a set of queries for displayto the user, wherein the set of queries correspond to one or more usecases of the glucose level control system; receiving a set of responsesto the set of queries; evaluating the set of responses to obtain anevaluation score; and determining based at least in part on theevaluation score whether the user is capable of safely using the glucoselevel control system with the second glucose level therapy control.

In a 388th example, the computer-implemented method of any of examples372-387, wherein said validating the user's capability to safely use theglucose level control system with the second glucose level therapycontrol configuration comprises evaluating use of the glucose levelcontrol system over an evaluation time period.

Terminology

It is to be understood that not necessarily all objects or advantagesmay be achieved in accordance with any particular embodiment describedherein. Thus, for example, those skilled in the art will recognize thatcertain embodiments may be configured to operate in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other objects or advantages as maybe taught or suggested herein.

All of the processes described herein may be embodied in, and fullyautomated via, software code modules executed by a computing system thatincludes one or more computers or processors. The code modules may bestored in any type of non-transitory computer-readable medium or othercomputer storage device. Some or all the methods may be embodied inspecialized computer hardware. Further, the computing system mayinclude, be implemented as part of, or communicate with an automatedblood glucose system, an ambulatory medicament system, or an ambulatorymedical device.

Many other variations than those described herein will be apparent fromthis disclosure. For example, depending on the embodiment, certain acts,events, or functions of any of the algorithms described herein can beperformed in a different sequence, can be added, merged, or left outaltogether (for example, not all described acts or events are necessaryfor the practice of the algorithms). Moreover, in certain embodiments,acts or events can be performed concurrently, for example, throughmulti-threaded processing, interrupt processing, or multiple processorsor processor cores or on other parallel architectures, rather thansequentially. In addition, different tasks or processes can be performedby different machines and/or computing systems that can functiontogether.

The various illustrative logical blocks and modules described inconnection with the embodiments disclosed herein can be implemented orperformed by a machine, such as a processing unit or processor, adigital signal processor (DSP), an application specific integratedcircuit (ASIC), a field programmable gate array (FPGA) or otherprogrammable logic device, discrete gate or transistor logic, discretehardware components, or any combination thereof designed to perform thefunctions described herein. A processor can be a microprocessor, but inthe alternative, the processor can be a controller, microcontroller, orstate machine, combinations of the same, or the like. A processor caninclude electrical circuitry configured to process computer-executableinstructions. In another embodiment, a processor includes an FPGA orother programmable device that performs logic operations withoutprocessing computer-executable instructions. A processor can also beimplemented as a combination of computing devices, for example, acombination of a DSP and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with a DSPcore, or any other such configuration. Although described hereinprimarily with respect to digital technology, a processor may alsoinclude primarily analog components. A computing environment can includeany type of computer system, including, but not limited to, a computersystem based on a microprocessor, a mainframe computer, a digital signalprocessor, a portable computing device, a device controller, or acomputational engine within an appliance, to name a few.

Conditional language such as, among others, “can,” “could,” “might” or“may,” unless specifically stated otherwise, are otherwise understoodwithin the context as used in general to convey that certain embodimentsinclude, while other embodiments do not include, certain features,elements and/or steps. Thus, such conditional language is not generallyintended to imply that features, elements and/or steps are in any wayrequired for one or more embodiments or that one or more embodimentsnecessarily include logic for deciding, with or without user input orprompting, whether these features, elements and/or steps are included orare to be performed in any particular embodiment.

Disjunctive language such as the phrase “at least one of X, Y, or Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to present that an item, term, etc., may beeither X, Y, or Z, or any combination thereof (for example, X, Y, and/orZ). Thus, such disjunctive language is not generally intended to, andshould not, imply that certain embodiments require at least one of X, atleast one of Y, or at least one of Z to each be present.

Any process descriptions, elements or blocks in the flow diagramsdescribed herein and/or depicted in the attached figures should beunderstood as potentially representing modules, segments, or portions ofcode which include one or more executable instructions for implementingspecific logical functions or elements in the process. Alternateimplementations are included within the scope of the embodimentsdescribed herein in which elements or functions may be deleted, executedout of order from that shown, or discussed, including substantiallyconcurrently or in reverse order, depending on the functionalityinvolved as would be understood by those skilled in the art.

Unless otherwise explicitly stated, articles such as “a” or “an” shouldgenerally be interpreted to include one or more described items.Accordingly, phrases such as “a device configured to” are intended toinclude one or more recited devices. Such one or more recited devicescan also be collectively configured to carry out the stated recitations.For example, “a processor configured to carry out recitations A, B andC” can include a first processor configured to carry out recitation Aworking in conjunction with a second processor configured to carry outrecitations B and C.

Many variations and modifications may be made to the above-describedembodiments, the elements of which are to be understood as being amongother acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure.

What is claimed is:
 1. An ambulatory medicament pump configured toenable therapy change controls associated with a selected safe accesslevel for a user of the ambulatory medicament pump configured to providemedicament therapy to a subject, the ambulatory medicament pumpcomprising: a pump controller configured to receive a dose controlsignal to cause the ambulatory medicament pump to infuse a medicamentfrom a medicament reservoir into a subject; a data interface configuredto communicate with an electronic access device; a non-transitory memoryconfigured to store specific computer-executable instructions and aplurality of safe access level profiles, each safe access level profilespecifying therapy change controls associated with a safe access level,wherein the therapy change controls comprise a control for selecting amedicament therapy setting that affects administration of medicamenttherapy by the ambulatory medicament pump; and a hardware processor incommunication with the non-transitory memory and configured to executethe specific computer-executable instructions to at least: receive, viathe data interface, an access signal from the electronic access device,wherein the access signal is configured to enable one or more therapychange controls associated with the selected safe access level; and inresponse to receiving the access signal, enable the one or more therapychange controls associated with a selected safe access level, whereinselecting a medicament therapy setting using the one or more therapychange controls causes modification of a control parameter used by acontrol algorithm to affect the administration of medicament therapy bythe ambulatory medicament pump.
 2. The ambulatory medicament pump ofclaim 1, wherein the ambulatory medicament pump is configured to providemedicament therapy to control a blood glucose level in the subject. 3.The ambulatory medicament pump of claim 2, wherein: the medicamenttherapy comprises insulin therapy; and the one or more therapy changecontrols comprise a control for selecting a type of the insulin therapyfrom a plurality of insulin therapy types.
 4. The ambulatory medicamentpump of claim 3, wherein the type of insulin therapy comprises U100insulin therapy, U200 insulin therapy, ultra-rapid insulin therapy, orfast-acting insulin therapy.
 5. The ambulatory medicament pump of claim1, wherein the control parameter is used by the control algorithm toaccount for an accumulation of insulin in the subject.
 6. The ambulatorymedicament pump of claim 1, wherein the one or more therapy changecontrols associated with the selected safe access level are enabledduring a validity period.
 7. The ambulatory medicament pump of claim 6,wherein the validity period expires when the subject associated with theambulatory medicament pump changes.
 8. The ambulatory medicament pump ofclaim 6, wherein the validity period is modified from a first period toa second period in response to a user interaction with a user interfaceof the ambulatory medicament pump.
 9. The ambulatory medicament pump ofclaim 1, wherein: the data interface is configured to communicate withthe electronic access device via a wired or a wireless communicationconnection; and the wireless communication connection comprises at leastone of: a Long-Term Evolution wireless connection, a Wi-Fi networkconnection, a 5G communication network connection, a wide area networkconnection, a near-field communication network connection, or ashort-range wireless connection.
 10. The ambulatory medicament pump ofclaim 1, wherein the electronic access device comprises a personalcomputer, a mobile phone, a dedicated electronic access device, a cloudserver, or a passcode server.
 11. The ambulatory medicament pump ofclaim 1, wherein the electronic access device comprises an electronicdevice associated with a healthcare provider or a trainer of the user orthe subject.
 12. The ambulatory medicament pump of claim 1, wherein theselected safe access level is associated with a therapy history of thesubject, a training level of the subject or the user, or a medicamentprescription of the subject.
 13. The ambulatory medicament pump of claim1, wherein the hardware processor is further configured to execute thespecific computer-executable instructions to at least enable the one ormore therapy change controls associated with the selected safe accesslevel by displaying therapy change control elements on a user interfacewherein the therapy change control elements enable modification ofcontrol parameter values corresponding to the one or more therapy changecontrols.
 14. The ambulatory medicament pump of claim 1, wherein thehardware processor is further configured to execute the specificcomputer-executable instructions to at least enable the one or moretherapy change controls associated with the selected safe access levelby unlocking therapy change control elements in a menu displayed on auser interface wherein the therapy change control elements enablemodification of control parameter values corresponding to the one ormore therapy change controls.
 15. The ambulatory medicament pump ofclaim 1, wherein the hardware processor is further configured to executethe specific computer-executable instructions to at least: receive,responsive to a user interaction with a user interface, a request torestore the control parameter to a previous value; and restore thecontrol parameter to the previous value.
 16. The ambulatory medicamentpump of claim 1, wherein the access signal comprises a time-basedpasscode associated with the safe access level, wherein the time-basedpasscode is configured to expire after a validity period, and wherein inresponse to receiving the access signal, the hardware processor isfurther configured to execute the specific computer-executableinstructions to at least: receive a user passcode in response to userinteraction with a passcode entry interface; determine that the userpasscode matches the time-based passcode and that the user passcode isreceived during the validity period; and in response to determining thatthe user passcode matches the time-based passcode and that the userpasscode is received during the validity period, enable the therapychange controls associated with the safe access level.
 17. Acomputer-implemented method of enabling therapy change controlsassociated with a selected safe access level for a user of an ambulatorymedicament pump configured to provide medicament therapy to a subject,wherein the medicament therapy comprises infusing a medicament to thesubject, the computer-implemented method comprising: by a hardwareprocessor of an ambulatory medicament pump, wherein the hardwareprocessor is configured to execute specific computer-executableinstructions stored in a non-transitory memory in communication with thehardware processor: receiving, via a digital data interface, an accesssignal from an electronic access device, wherein the access signal isconfigured to enable one or more therapy change controls associated witha selected safe access level, wherein the selected safe access level isassociated with at least one of a plurality of safe access levelprofiles, each safe access level profile specifying therapy changecontrols associated with a safe access level, and wherein the one ormore therapy change controls affect administration of medicament therapyby the ambulatory medicament pump; and in response to receiving theaccess signal, enabling the one or more therapy change controlsassociated with the safe access level, wherein selecting a medicamenttherapy setting using the one or more therapy change controls causesmodification of a control parameter used by a control algorithm toaffect administration of the medicament therapy by the ambulatorymedicament pump.
 18. The computer-implemented method of claim 17,wherein: the ambulatory medicament pump is configured to providemedicament therapy comprising insulin therapy; and the one or moretherapy change controls comprise a control for selecting a type of theinsulin therapy from a plurality of insulin therapy types.
 19. Thecomputer-implemented method of claim 17, wherein the one or more therapychange controls associated with the selected safe access level areenabled during a validity period.
 20. The computer-implemented method ofclaim 17, wherein the safe access level is associated with a therapyhistory of a subject, a training level of the subject or a user, or amedicament prescription of the subject.
 21. The computer-implementedmethod of claim 17, wherein enabling the one or more therapy changecontrols associated with the selected safe access level comprisesdisplaying therapy change control elements on a user interface, andwherein the therapy change control elements enable modification ofcontrol parameter values corresponding to the therapy change controls.22. The computer-implemented method of claim 17, wherein enabling theone or more therapy change controls associated with the selected safeaccess level comprises unlocking therapy change control elements in amenu displayed on a user interface, and wherein the therapy changecontrol elements enable modification of control parameter valuescorresponding to the therapy change controls.
 23. Thecomputer-implemented method of claim 17, further comprising: receiving,responsive to user interaction with a user interface, a request torestore the control parameter to a previous value; and restoring thecontrol parameter to the previous value.
 24. The computer-implementedmethod of claim 17, wherein the access signal corresponds to atime-based passcode associated with the safe access level, wherein thetime-based passcode is configured to expire after a validity period, andwherein the computer-implemented method further comprises: receiving auser passcode in response to user interaction with a passcode entryinterface; determining that the user passcode matches the time-basedpasscode and that the user passcode is received during the validityperiod; and in response to determining that the user passcode matchesthe time-based passcode and that the user passcode is received duringthe validity period, enabling the therapy change controls associatedwith the safe access level.
 25. A computer-implemented method ofmanaging access to therapy change controls of an ambulatory medicamentpump configured to provide medicament therapy to a subject, thecomputer-implemented method comprising: by a hardware processor of anelectronic evaluation device, wherein the hardware processor isconfigured to execute specific computer-executable instructions storedin the electronic evaluation device to determine a safe access levelfrom a plurality of safe access levels: receiving, from an electronicdevice in communication with the electronic evaluation device,evaluation data associated with a subject, wherein the evaluation datacomprises therapy data corresponding to glycemic control of the subjectby an ambulatory medicament pump; determining the safe access level fora user of the ambulatory medicament pump based at least in part on theevaluation data, wherein the safe access level is associated with aplurality of therapy change controls of the ambulatory medicament pump,and wherein the plurality of therapy change controls comprise a controlfor selecting a medicament therapy setting that affects administrationof medicament therapy by the ambulatory medicament pump; determining,based at least in part on the evaluation data, a validity period duringwhich the plurality of therapy change controls are enabled; generatingan access signal that, when received by the ambulatory medicament pump,is configured to cause the plurality of therapy change controls to beenabled during the validity period; and transmitting the access signalto the ambulatory medicament pump via a data connection.
 26. Thecomputer-implemented method of claim 25, wherein the ambulatorymedicament pump is configured to provide medicament therapy to control aglucose level in the subject.
 27. The computer-implemented method ofclaim 26, wherein: the medicament comprises insulin; and the pluralityof therapy change controls comprise a control for selecting a type ofinsulin.
 28. The computer-implemented method of claim 25, wherein thesafe access level is selected based at least in part on a medicamentprescription of the subject.
 29. The computer-implemented method ofclaim 25, wherein the validity period is extendable or renewable inresponse to receiving an extension or renewal request.
 30. Thecomputer-implemented method of claim 25, wherein generating the accesssignal comprises generating a time-based passcode associated with thesafe access level, and wherein receipt of a user passcode that matchesthe time-based passcode, by the ambulatory medicament pump from theuser, causes the ambulatory medicament pump to enable the therapy changecontrols associated with the safe access level.